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RecallWatchMedical Device Safety
Class IIOngoingZ-2622-2025

Mindray DS USA, Inc. Dba Mindray North America recalls BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017

Mindray DS USA, Inc. dba Mindray North AmericaMahwah, NJ, United StatesReported Oct 1, 2025 · 9 months ago
Legal News Analyst ·

Reason for recall

Potential for activation of an abnormal alarm pause.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

Lot / code information

UDI
06944904094922) with software version versions 01.04.00.01, 01.05.00.01, 01.06.00.01, 01.06.01.01: 1. N1 Nellcor:
Part / Item #
6660E-PA00010
Serial #
AA3-06023768, AA3-06023476, AA3-03014849. 2. Used N1 Nellcor:
Part / Item #
Q6660E-PA00010
Serial #
AA3-8C003924. 3. N1 Nellcor, ST:
Part / Item #
6660E-PA00011
Serial #
AA3-92004799, AA3-06023994, AA3-03014853, AA3-03014857, AA3-03014701, AA3-03014714 — +354 moreShow all
AA3-92004799, AA3-06023994, AA3-03014853, AA3-03014857, AA3-03014701, AA3-03014714, AA3-03014848, AA3-03014850, AA3-03014861, AA3-03014865, AA3-04017814, AA3-06024001, AA3-03014700, AA3-03014702, AA3-03014703, AA3-03014705, AA3-03014707, AA3-03014710, AA3-03014854, AA3-03014859, AA3-03014862, AA3-03014864, AA3-03014867, AA3-9C011900, AA3-9C011901, AA3-9C011905, AA3-9C011916, AA3-9C011918, AA3-9C011920, AA3-02013653, AA3-02013654, AA3-02013655, AA3-02013656, AA3-02013657, AA3-07024289, AA3-94006408, AA3-97007795, AA3-98008764, AA3-98008766, AA3-98008774, AA3-98008789, AA3-98008799, AA3-98008801, AA3-98008802, AA3-9C011260, AA3-9C011240, AA3-9C011242, AA3-9C011249, AA3-9C011259, AA3-03014712, AA3-05021468, AA3-97007785, AA3-97007786, AA3-97007787, AA3-97007788, AA3-97007789, AA3-97007790, AA3-97007791, AA3-97007792, AA3-97007794, AA3-97007796, AA3-97007797, AA3-97007798, AA3-97007799, AA3-97007800, AA3-97007801, AA3-97007802, AA3-97007803, AA3-97007804, AA3-97007805, AA3-97007806, AA3-97007808, AA3-97007809, AA3-97007810, AA3-97007811, AA3-97007812, AA3-97007813, AA3-97007814, AA3-97007815, AA3-97007816, AA3-97007817, AA3-97007818, AA3-97007819, AA3-97007821, AA3-97007822, AA3-97007823, AA3-97007824, AA3-97007825, AA3-97007826, AA3-97007827, AA3-97007828, AA3-97007829, AA3-98008767, AA3-98008772, AA3-98008773, AA3-98008806, AA3-98008807, AA3-98008808, AA3-98008809, AA3-98008810, AA3-98008811, AA3-98008812, AA3-98008813, AA3-98008814, AA3-98008816, AA3-98008817, AA3-98008818, AA3-98008819, AA3-98008821, AA3-98008822, AA3-98008823, AA3-98008824, AA3-98008825, AA3-98008985, AA3-98008986, AA3-98008987, AA3-98008988, AA3-98008989, AA3-98008990, AA3-98008991, AA3-98008993, AA3-98008994, AA3-98008995, AA3-98008996, AA3-98008997, AA3-98008998, AA3-98008999, AA3-98009000, AA3-98009001, AA3-98009002, AA3-98009003, AA3-98009004, AA3-98009106, AA3-98009109, AA3-9C011896, AA3-9C011910, AA3-9C011914, AA3-98009110, AA3-98009117, AA3-98009120, AA3-07024284, AA3-07024306, AA3-06024000, AA3-05020241, AA3-05020250, AA3-05021448, AA3-9C011915, AA3-9C011919, AA3-94006405, AA3-94006407, AA3-94006598, AA3-94006599, AA3-94006600, AA3-94006601, AA3-07024268, AA3-07024285, AA3-07024287, AA3-07024295, AA3-07024301, AA3-07024302, AA3-03014869, AA3-92004800, AA3-94006409, AA3-94006415, AA3-98008763, AA3-98008769, AA3-98008775, AA3-98008777, AA3-98008783, AA3-98008784, AA3-98008785, AA3-98008791, AA3-98008796, AA3-9C011244, AA3-07024292, AA3-05021350, AA3-05021353, AA3-05021356, AA3-05021440, AA3-06023481, AA3-06023489, AA3-06023495, AA3-06024075, AA3-06023765, AA3-06024045, AA3-06024047, AA3-07024293, AA3-07024303, AA3-03014855, AA3-03014856, AA3-03014858, AA3-03014863, AA3-03014866, AA3-03014868, AA3-07024307, AA3-06024007, AA3-07024263, AA3-92004801, AA3-94005815, AA3-94006402, AA3-94006410, AA3-98009103, AA3-98009104, AA3-98009105, AA3-98009107, AA3-98009108, AA3-98009111, AA3-98009112, AA3-98009114, AA3-98009115, AA3-98009119, AA3-98009121, AA3-98009122, AA3-9C011236, AA3-9C011237, AA3-9C011238, AA3-9C011239, AA3-9C011243, AA3-9C011245, AA3-9C011246, AA3-9C011247, AA3-9C011248, AA3-9C011250, AA3-9C011251, AA3-9C011252, AA3-9C011253, AA3-9C011254, AA3-9C011255, AA3-9C011256, AA3-9C011257, AA3-9C011258, AA3-9C011902, AA3-03014704, AA3-03014706, AA3-03014711, AA3-04017479, AA3-04017486, AA3-04017490, AA3-04017492, AA3-04017495, AA3-04017498, AA3-04017775, AA3-04017776, AA3-04017779, AA3-04017780, AA3-04017781, AA3-04017782, AA3-04017783, AA3-04017786, AA3-04017788, AA3-04017789, AA3-04017792, AA3-04017918, AA3-04017919, AA3-04017920, AA3-04017921, AA3-04017922, AA3-04017923, AA3-04017924, AA3-04017925, AA3-04017926, AA3-04017927, AA3-04017928, AA3-04017929, AA3-04017931, AA3-04017932, AA3-06024004, AA3-07024280, AA3-07024255, AA3-07024410, AA3-07024424, AA3-92004796, AA3-92004797, AA3-94005814, AA3-94005816, AA3-94005817, AA3-94005818, AA3-94005819, AA3-94005820, AA3-94005821, AA3-94005822, AA3-94005823, AA3-94006411, AA3-98009118, AA3-05021348, AA3-05021352, AA3-06024002, AA3-06024012, AA3-06024029, AA3-06024031, AA3-06024035, AA3-06024049, AA3-06024050, AA3-06024055, AA3-05021359, AA3-06023471, AA3-06023760, AA3-07024294, AA3-03014713, AA3-03014851, AA3-03014870, AA3-03014871, AA3-03014872, AA3-04017480, AA3-04017481, AA3-04017482, AA3-04017483, AA3-04017484, AA3-04017485, AA3-04017487, AA3-04017488, AA3-04017489, AA3-04017493, AA3-04017494, AA3-04017496, AA3-04017497, AA3-04017773, AA3-04017774, AA3-04017777, AA3-04017778, AA3-04017784, AA3-04017787, AA3-04017791, AA3-04017930, AA3-07024283, AA3-07024286, AA3-07024288, AA3-07024291, AA3-07024296, AA3-07024297, AA3-07024298, AA3-07024299, AA3-07024300, AA3-07024304, AA3-07024305, AA3-07024308, AA3-07024309, AA3-07024310, AA3-07024311, AA3-07024312, AA3-04017785, AA3-05021345, AA3-05021354, AA3-06024067, AA3-94006413, AA3-98008780, AA3-06024038, AA3-06024042, AA3-04017794, AA3-05021451, AA3-05021459, AA3-06023746, AA3-06023754, AA3-06024043, AA3-06024046, AA3-06024063, AA3-06024077, AA3-07024251, AA3-94006403. 4. Used N1 Nellcor, ST:
Part / Item #
Q6660E-PA00011
Serial #
AA3-98009113. 5. N1 Nellcor, ST, Glasgow:
Part / Item #
6660E-PA00012
Show 21 more code fields
Serial #
AA3-07024253, AA3-07024274, AA3-07024279, AA3-07024406, AA3-92004803, AA3-92004805 — +675 moreShow all
AA3-07024253, AA3-07024274, AA3-07024279, AA3-07024406, AA3-92004803, AA3-92004805, AA3-06024066, AA3-02013517, AA3-02013525, AA3-02013526, AA3-02013531, AA3-02013536, AA3-02013594, AA3-02013607, AA3-02013612, AA3-02013615, AA3-02013616, AA3-02013618, AA3-02013622, AA3-02013627, AA3-02013629, AA3-02013632, AA3-02013633, AA3-02013634, AA3-02013635, AA3-02013636, AA3-02013639, AA3-02013640, AA3-02013643, AA3-02013647, AA3-02013648, AA3-02013649, AA3-02013650, AA3-02013652, AA3-02013678, AA3-02013679, AA3-02013680, AA3-02013681, AA3-02013682, AA3-03014874, AA3-03014908, AA3-07024401, AA3-04017799, AA3-92004802, AA3-94005825, AA3-94005826, AA3-94005827, AA3-94005828, AA3-94005829, AA3-94006427, AA3-94006430, AA3-98009389, AA3-94006605, AA3-07024258, AA3-07024262, AA3-07024411, AA3-07024414, AA3-07024417, AA3-07024418, AA3-05020252, AA3-99009610, AA3-99009611, AA3-99009612, AA3-99009613, AA3-99009614, AA3-99009615, AA3-99009616, AA3-99009617, AA3-99009618, AA3-99009619, AA3-99009620, AA3-99009621, AA3-99009622, AA3-99009623, AA3-99009625, AA3-99009626, AA3-99009627, AA3-99009628, AA3-99009629, AA3-99009630, AA3-99009631, AA3-99009632, AA3-99009633, AA3-99009634, AA3-99009635, AA3-99009637, AA3-99009638, AA3-99009684, AA3-99009685, AA3-99009690, AA3-99009704, AA3-99009707, AA3-99009711, AA3-99009714, AA3-99009717, AA3-99009721, AA3-99009722, AA3-99009724, AA3-99009727, AA3-99009730, AA3-99009731, AA3-99009735, AA3-99009736, AA3-99009737, AA3-99009739, AA3-99009743, AA3-99009748, AA3-99009750, AA3-99009756, AA3-99009757, AA3-99009768, AA3-99009772, AA3-99009774, AA3-99009775, AA3-99009777, AA3-99009778, AA3-99009780, AA3-99009782, AA3-03014909, AA3-03014916, AA3-03014917, AA3-03014920, AA3-03014675, AA3-03014676, AA3-03014681, AA3-03014697, AA3-04017499, AA3-04017500, AA3-04017501, AA3-04017502, AA3-04017503, AA3-04017504, AA3-04017505, AA3-04017506, AA3-04017508, AA3-05020230, AA3-05020231, AA3-05020235, AA3-05020240, AA3-05020242, AA3-05020246, AA3-05020247, AA3-05020248, AA3-05020253, AA3-05020256, AA3-05020257, AA3-98008977, AA3-99009706, AA3-99009779, AA3-02013674, AA3-03013797, AA3-03014660, AA3-03014662, AA3-03014663, AA3-03014664, AA3-03014667, AA3-03014668, AA3-03014670, AA3-03014671, AA3-03014672, AA3-03014673, AA3-03014674, AA3-03014677, AA3-03014678, AA3-03014679, AA3-03014680, AA3-03014682, AA3-03014683, AA3-03014684, AA3-03014686, AA3-03014688, AA3-03014690, AA3-03014691, AA3-03014695, AA3-03014698, AA3-04017507, AA3-06023454, AA3-06023455, AA3-06023456, AA3-06023458, AA3-06023461, AA3-06023463, AA3-06023465, AA3-06023467, AA3-06023468, AA3-06023473, AA3-06023474, AA3-99009686, AA3-99009687, AA3-99009688, AA3-99009689, AA3-99009691, AA3-99009692, AA3-99009695, AA3-99009696, AA3-99009697, AA3-99009698, AA3-99009699, AA3-99009702, AA3-99009712, AA3-99009713, AA3-99009716, AA3-99009726, AA3-99009728, AA3-99009729, AA3-99009732, AA3-9C011261, AA3-9C011262, AA3-9C011263, AA3-9C011264, AA3-9C011266, AA3-9C011267, AA3-9C011268, AA3-9C011270, AA3-9C011271, AA3-9C011274, AA3-9C011275, AA3-9C011276, AA3-9C011277, AA3-9C011278, AA3-9C011279, AA3-9C011280, AA3-9C011921, AA3-9C011922, AA3-9C011923, AA3-9C011925, AA3-9C011930, AA3-9C011931, AA3-9C011932, AA3-9C011933, AA3-9C011934, AA3-9C011935, AA3-9C011936, AA3-9C011937, AA3-9C011938, AA3-9C011939, AA3-9C011940, AA3-9C012025, AA3-9C012026, AA3-9C012027, AA3-9C012028, AA3-9C012029, AA3-9C012030, AA3-9C012031, AA3-9C012032, AA3-9C012033, AA3-9C012034, AA3-9C012035, AA3-9C012036, AA3-9C012037, AA3-9C012038, AA3-9C012039, AA3-9C012040, AA3-9C012041, AA3-9C012042, AA3-9C012043, AA3-9C012044, AA3-06024006, AA3-06024052, AA3-07024277, AA3-07024404, AA3-8C003930, AA3-91004195, AA3-91004196, AA3-06024062, AA3-07024403, AA3-03014666, AA3-03014669, AA3-03014694, AA3-04017796, AA3-04017801, AA3-04017808, AA3-04017810, AA3-04017811, AA3-04017812, AA3-04017813, AA3-04017816, AA3-04017817, AA3-05020229, AA3-05020232, AA3-05020236, AA3-05020245, AA3-04017795, AA3-06023453, AA3-06023464, AA3-06023488, AA3-04017798, AA3-04017800, AA3-04017804, AA3-04017806, AA3-06023457, AA3-06023462, AA3-06023466, AA3-06023469, AA3-06023470, AA3-06023472, AA3-06023475, AA3-06023477, AA3-06023478, AA3-06023480, AA3-06023482, AA3-06023483, AA3-06023484, AA3-06023485, AA3-06023486, AA3-06023487, AA3-06023490, AA3-06023491, AA3-06023493, AA3-06023494, AA3-06023496, AA3-06023497, AA3-06023498, AA3-06023499, AA3-06023500, AA3-06023502, AA3-06023995, AA3-06023996, AA3-06023997, AA3-06023998, AA3-06024005, AA3-06024034, AA3-06024037, AA3-06024039, AA3-06024040, AA3-06024041, AA3-06024044, AA3-06024051, AA3-06024054, AA3-06024057, AA3-06024058, AA3-06024059, AA3-06024060, AA3-06024061, AA3-06024065, AA3-06024068, AA3-06024071, AA3-06024073, AA3-06024070, AA3-07024254, AA3-07024256, AA3-07024270, AA3-07024271, AA3-07024272, AA3-07024273, AA3-07024278, AA3-07024282, AA3-07024394, AA3-07024396, AA3-07024398, AA3-07024408, AA3-07024420, AA3-07024423, AA3-02013477, AA3-02013479, AA3-02013480, AA3-02013482, AA3-02013483, AA3-02013484, AA3-02013485, AA3-02013486, AA3-02013489, AA3-02013493, AA3-02013495, AA3-02013496, AA3-02013497, AA3-02013501, AA3-02013503, AA3-07024402, AA3-07024412, AA3-07024413, AA3-94005824, AA3-94006417, AA3-94006418, AA3-94006419, AA3-94006420, AA3-94006421, AA3-94006422, AA3-94006423, AA3-94006424, AA3-94006425, AA3-94006426, AA3-94006428, AA3-94006429, AA3-94006431, AA3-94006602, AA3-94006604, AA3-94006606, AA3-98008751, AA3-98008752, AA3-98008753, AA3-98008754, AA3-98008755, AA3-98008756, AA3-98008757, AA3-98008758, AA3-98008759, AA3-98008760, AA3-98009390, AA3-98009391, AA3-98009392, AA3-98009394, AA3-98009395, AA3-98009396, AA3-02013604, AA3-03013803, AA3-03014665, AA3-03014685, AA3-03014687, AA3-03014689, AA3-03014692, AA3-03014693, AA3-03014696, AA3-03014699, AA3-03014873, AA3-03014875, AA3-03014877, AA3-03014878, AA3-03014879, AA3-03014882, AA3-03014911, AA3-03014913, AA3-03014915, AA3-03014919, AA3-03014921, AA3-03014922, AA3-03014925, AA3-03014929, AA3-0702 …
Part / Item #
Q6660E-PA00012
Serial #
AA3-92004804. 7. N1 Nellcor, ST, CO2:
Part / Item #
6660E-PA00014
Serial #
AA3-8C003786, AA3-8C003788, AA3-8C003783, AA3-8C003785, AA3-8C003790, AA3-8C003792, AA3-8C003791. 8. N1 Nellcor, ST, Glasgow, CO2:
Part / Item #
6660E-PA00015
Serial #
AA3-07024199, AA3-07024200, AA3-07024204, AA3-07024226, AA3-91004524, AA3-91004526 — +69 moreShow all
AA3-07024199, AA3-07024200, AA3-07024204, AA3-07024226, AA3-91004524, AA3-91004526, AA3-04017459, AA3-04017461, AA3-04017463, AA3-04017466, AA3-04017469, AA3-04017470, AA3-04017471, AA3-04017472, AA3-04017473, AA3-04017475, AA3-04017477, AA3-04017478, AA3-05021394, AA3-06024022, AA3-06024028, AA3-04017512, AA3-04017514, AA3-04017518, AA3-05021366, AA3-05021368, AA3-05021370, AA3-05021371, AA3-05021372, AA3-05021376, AA3-05021377, AA3-05021378, AA3-05021381, AA3-05021382, AA3-05021383, AA3-05021384, AA3-05021385, AA3-05021387, AA3-05021390, AA3-05021391, AA3-05021392, AA3-05021393, AA3-06023012, AA3-06023014, AA3-06024015, AA3-06024020, AA3-06024024, AA3-06024025, AA3-97007830, AA3-06023010, AA3-06023016, AA3-06024017, AA3-91004508, AA3-91004515, AA3-91004522, AA3-91004528, AA3-91004530, AA3-92004695, AA3-92004697, AA3-92004700, AA3-92004703, AA3-93005732, AA3-93005734, AA3-93005736, AA3-93005737, AA3-94005831, AA3-94005930, AA3-94005931, AA3-94006096, AA3-94006099, AA3-94006118, AA3-97007831, AA3-97007832, AA3-97007833, AA3-97007834. 9. N1 Masimo:
Part / Item #
6660E-PA00016
Serial #
AA3-07024186, AA3-98009341, AA3-94006610, AA3-94006622, AA3-94006624, AA3-94006627 — +31 moreShow all
AA3-07024186, AA3-98009341, AA3-94006610, AA3-94006622, AA3-94006624, AA3-94006627, AA3-94006629, AA3-94006635, AA3-94006639, AA3-98009237, AA3-98009238, AA3-98009239, AA3-98009240, AA3-98009241, AA3-98009243, AA3-98009244, AA3-98009245, AA3-98009248, AA3-98009250, AA3-98009251, AA3-07024347, AA3-07024343, AA3-07024344, AA3-07024352, AA3-07024356, AA3-07024360, AA3-07024366, AA3-07024367, AA3-07024370, AA3-04015340, AA3-07024357, AA3-07024358, AA3-07024368, AA3-07024369, AA3-06024135, AA3-06024156. 10. N1 Masimo, ST:
Part / Item #
6660E-PA00017
Serial #
AA3-01012327, AA3-01012342, AA3-04015327, AA3-04015332, AA3-05021450, AA3-05021453 — +409 moreShow all
AA3-01012327, AA3-01012342, AA3-04015327, AA3-04015332, AA3-05021450, AA3-05021453, AA3-98009257, AA3-9C011283, AA3-9C011285, AA3-9C011291, AA3-9C011294, AA3-93005039, AA3-93005040, AA3-93005041, AA3-94005920, AA3-03015119, AA3-03015128, AA3-03015129, AA3-03015132, AA3-03015133, AA3-07024188, AA3-04015336, AA3-05021420, AA3-05021424, AA3-05021444, AA3-07024342, AA3-07024349, AA3-07024350, AA3-07024364, AA3-92004808, AA3-92004809, AA3-92004810, AA3-92004811, AA3-92004813, AA3-92004814, AA3-92004815, AA3-92004816, AA3-92004817, AA3-93005036, AA3-93005042, AA3-94006638, AA3-04015341, AA3-04015357, AA3-01012347, AA3-04015342, AA3-94006434, AA3-94006438, AA3-94006439, AA3-94006441, AA3-94006448, AA3-94006455, AA3-98009253, AA3-98009254, AA3-98009310, AA3-98009316, AA3-98009335, AA3-98009336, AA3-98009340, AA3-98009343, AA3-98009258, AA3-98009261, AA3-98009273, AA3-98009318, AA3-98009342, AA3-07024248, AA3-98009264, AA3-98009272, AA3-98009347, AA3-04015350, AA3-04015352, AA3-06023750, AA3-06023757, AA3-05021466, AA3-06023767, AA3-07024249, AA3-98009135, AA3-98009137, AA3-98009242, AA3-98009246, AA3-06023749, AA3-07024183, AA3-07024231, AA3-07024232, AA3-07024235, AA3-07024238, AA3-07024252, AA3-01012323, AA3-01012324, AA3-01012325, AA3-01012326, AA3-07024192, AA3-05021449, AA3-05021464, AA3-94006632, AA3-04015349, AA3-05021458, AA3-06023745, AA3-07024194, AA3-07024228, AA3-01012351, AA3-98009260, AA3-98009265, AA3-98009269, AA3-98009270, AA3-98009271, AA3-98009304, AA3-98009306, AA3-98009307, AA3-98009311, AA3-98009313, AA3-98009324, AA3-98009329, AA3-98009330, AA3-98009338, AA3-9C011282, AA3-9C011284, AA3-9C011286, AA3-9C011287, AA3-9C011288, AA3-9C011289, AA3-04015324, AA3-93005033, AA3-94006454, AA3-94006456, AA3-94006607, AA3-94006609, AA3-94006613, AA3-94006614, AA3-94006616, AA3-94006619, AA3-94006626, AA3-94006628, AA3-94006633, AA3-94006634, AA3-94006636, AA3-94006640, AA3-05021456, AA3-05021460, AA3-05021467, AA3-06023753, AA3-06023762, AA3-06023764, AA3-07024354, AA3-07024365, AA3-06023759, AA3-06023766, AA3-06023769, AA3-07024174, AA3-07024176, AA3-07024177, AA3-07024180, AA3-07024181, AA3-07024182, AA3-07024185, AA3-07024189, AA3-07024190, AA3-07024191, AA3-07024195, AA3-07024196, AA3-07024197, AA3-07024229, AA3-07024230, AA3-07024233, AA3-07024234, AA3-07024236, AA3-07024237, AA3-07024239, AA3-07024240, AA3-07024241, AA3-07024243, AA3-07024244, AA3-07024246, AA3-07024247, AA3-07024250, AA3-01012328, AA3-98009247, AA3-98009305, AA3-98009322, AA3-98009333, AA3-04015333, AA3-04015354, AA3-04015346, AA3-04015348, AA3-05021446, AA3-05021457, AA3-06023748, AA3-06023752, AA3-06023761, AA3-05021396, AA3-05021406, AA3-05021410, AA3-05021414, AA3-05021418, AA3-05021435, AA3-07024341, AA3-07024345, AA3-07024348, AA3-07024351, AA3-07024355, AA3-07024362, AA3-07024363, AA3-93005035, AA3-93005037, AA3-94005915, AA3-94005916, AA3-94005917, AA3-94005918, AA3-94005921, AA3-94005922, AA3-94005923, AA3-94005925, AA3-94005926, AA3-94005929, AA3-03014885, AA3-03014887, AA3-03014894, AA3-03014898, AA3-03014904, AA3-03014905, AA3-98009125, AA3-98009127, AA3-98009129, AA3-98009133, AA3-07024359, AA3-98009130, AA3-98009327, AA3-98009344, AA3-04015325, AA3-04015326, AA3-04015330, AA3-04015331, AA3-04015335, AA3-04015337, AA3-04015339, AA3-04015344, AA3-04015345, AA3-04015347, AA3-04015351, AA3-04015355, AA3-04015356, AA3-98009123, AA3-98009124, AA3-98009126, AA3-98009128, AA3-98009132, AA3-98009136, AA3-94005919, AA3-94005928, AA3-94006443, AA3-94006444, AA3-94006445, AA3-94006446, AA3-94006447, AA3-94006451, AA3-94006452, AA3-94006453, AA3-94006459, AA3-94006460, AA3-94006461, AA3-03014721, AA3-03015120, AA3-03015121, AA3-03015122, AA3-03015124, AA3-03015125, AA3-03015126, AA3-03015127, AA3-03015130, AA3-03015131, AA3-05021469, AA3-06023758, AA3-98009274, AA3-98009320, AA3-98009331, AA3-98009345, AA3-98009348, AA3-9C011281, AA3-9C011290, AA3-9C011292, AA3-9C011293, AA3-9C011295, AA3-98009249, AA3-94006432, AA3-94006433, AA3-94006435, AA3-94006436, AA3-94006437, AA3-94006440, AA3-94006442, AA3-94006449, AA3-94006457, AA3-94006458, AA3-05021425, AA3-03014715, AA3-03014716, AA3-03014717, AA3-03014719, AA3-03014723, AA3-03014724, AA3-03014725, AA3-03014726, AA3-03014727, AA3-03014728, AA3-03014729, AA3-03014730, AA3-03014732, AA3-03014733, AA3-03014734, AA3-03014883, AA3-03014886, AA3-03014892, AA3-03014893, AA3-03014896, AA3-03014897, AA3-03014900, AA3-03014903, AA3-03014906, AA3-03014907, AA3-04015329, AA3-04015334, AA3-04015338, AA3-04015358, AA3-94006450, AA3-94006615, AA3-94006617, AA3-94006618, AA3-94006620, AA3-94006621, AA3-94006623, AA3-94006630, AA3-94006631, AA3-94006637, AA3-94006641, AA3-01012329, AA3-01012331, AA3-01012332, AA3-01012333, AA3-01012334, AA3-01012336, AA3-01012337, AA3-01012338, AA3-01012339, AA3-01012340, AA3-01012343, AA3-01012344, AA3-01012345, AA3-01012346, AA3-03014884, AA3-03014888, AA3-03014889, AA3-03014890, AA3-03014891, AA3-03014895, AA3-03014899, AA3-03014901, AA3-03014902, AA3-9C011941, AA3-9C011942, AA3-9C011943, AA3-9C011944, AA3-9C011945, AA3-9C011946, AA3-03014722, AA3-98009263, AA3-98009332, AA3-01012349, AA3-01012350, AA3-01012322, AA3-06023751, AA3-06023763, AA3-07024175, AA3-04015343, AA3-98009134, AA3-9C011957, AA3-9C011958, AA3-9C011959, AA3-9C011960, AA3-07024346, AA3-07024353, AA3-93005038, AA3-94005924, AA3-94005927, AA3-9C011947, AA3-9C011948, AA3-9C011949, AA3-9C011950, AA3-9C011951, AA3-9C011952, AA3-9C011953, AA3-9C011954, AA3-9C011955, AA3-9C011956, AA3-01012330, AA3-01012341, AA3-03014720, AA3-03014731, AA3-98009252, AA3-98009255, AA3-98009259, AA3-98009262, AA3-98009267, AA3-98009275, AA3-98009276, AA3-98009308, AA3-98009309, AA3-98009312, AA3-98009317, AA3-98009319, AA3-98009321, AA3-98009328, AA3-98009334, AA3-98009337, AA3-98009346. 11. N1Masimo, ST, Glasgow:
Part / Item #
6660E-PA00018
Serial #
AA3-05020485, AA3-05020505, AA3-05021428, AA3-96007582, AA3-96007587, AA3-96007588 — +569 moreShow all
AA3-05020485, AA3-05020505, AA3-05021428, AA3-96007582, AA3-96007587, AA3-96007588, AA3-96007591, AA3-96007592, AA3-97008341, AA3-97008342, AA3-97008343, AA3-97008344, AA3-97008346, AA3-97008348, AA3-97008349, AA3-97008352, AA3-06023730, AA3-06024133, AA3-06024143, AA3-06024146, AA3-06024153, AA3-06024160, AA3-06024164, AA3-8C003880, AA3-8C003918, AA3-8C003939, AA3-8C003940, AA3-05021347, AA3-05021355, AA3-05021357, AA3-05021358, AA3-05021362, AA3-05021363, AA3-05021409, AA3-06023724, AA3-06023725, AA3-06023728, AA3-06023732, AA3-06023733, AA3-06023735, AA3-06023739, AA3-03013820, AA3-03013828, AA3-03013829, AA3-03013833, AA3-03013838, AA3-03013840, AA3-03013905, AA3-03013916, AA3-8C003858, AA3-8C003881, AA3-8C003888, AA3-8C003893, AA3-8C003898, AA3-8C003907, AA3-8C003908, AA3-8C003910, AA3-9C011961, AA3-9C011962, AA3-9C011963, AA3-9C011964, AA3-9C011965, AA3-9C011966, AA3-9C011967, AA3-9C011968, AA3-9C011969, AA3-9C011970, AA3-9C011971, AA3-9C011972, AA3-9C011973, AA3-9C011975, AA3-9C011976, AA3-9C011985, AA3-9C012045, AA3-9C012046, AA3-9C012047, AA3-9C012054, AA3-9C012064, AA3-9C012065, AA3-9C012066, AA3-9C012067, AA3-9C012068, AA3-9C012069, AA3-01012357, AA3-04015259, AA3-05020324, AA3-05020332, AA3-05020507, AA3-06023737, AA3-97008509, AA3-97008519, AA3-05021351, AA3-05021360, AA3-05021361, AA3-8C003887, AA3-96007580, AA3-96007581, AA3-96007584, AA3-97008345, AA3-97008347, AA3-97008350, AA3-97008503, AA3-97008507, AA3-97008508, AA3-97008510, AA3-97008511, AA3-97008514, AA3-97008515, AA3-97008516, AA3-97008518, AA3-97008520, AA3-97008521, AA3-97008525, AA3-97008527, AA3-97008528, AA3-97008530, AA3-9C011296, AA3-9C011297, AA3-9C011298, AA3-9C011299, AA3-9C011300, AA3-9C011301, AA3-9C011302, AA3-9C011303, AA3-9C011304, AA3-9C011305, AA3-9C011306, AA3-9C011307, AA3-9C011308, AA3-9C011309, AA3-9C011310, AA3-9C011311, AA3-9C011312, AA3-9C011313, AA3-9C011314, AA3-9C011316, AA3-9C011317, AA3-9C011318, AA3-9C011319, AA3-9C011320, AA3-9C011321, AA3-9C011322, AA3-9C011323, AA3-9C011324, AA3-9C011325, AA3-9C011326, AA3-9C011327, AA3-9C011328, AA3-9C011329, AA3-9C011330, AA3-9C011331, AA3-9C011332, AA3-9C011333, AA3-9C011334, AA3-9C011335, AA3-05020360, AA3-8C003912, AA3-96007578, AA3-96007579, AA3-97008338, AA3-8C003869, AA3-8C003873, AA3-03013832, AA3-03013842, AA3-03013848, AA3-04016700, AA3-04016704, AA3-04016705, AA3-04016706, AA3-05020296, AA3-05021423, AA3-05021427, AA3-05021429, AA3-05021430, AA3-05021438, AA3-06024134, AA3-9C011979, AA3-9C011986, AA3-9C012049, AA3-9C012050, AA3-9C012058, AA3-9C012060, AA3-9C012061, AA3-05020475, AA3-05021407, AA3-05021404, AA3-05021405, AA3-05021415, AA3-05021417, AA3-05021419, AA3-05021432, AA3-01012352, AA3-01012356, AA3-01012359, AA3-04016711, AA3-05021408, AA3-05021436, AA3-03013830, AA3-04016698, AA3-05021398, AA3-05021399, AA3-05021411, AA3-05021412, AA3-05021431, AA3-04016701, AA3-04016702, AA3-04016707, AA3-04016709, AA3-04016710, AA3-04016712, AA3-03013812, AA3-03013847, AA3-03013911, AA3-03013917, AA3-05020347, AA3-05020354, AA3-05020356, AA3-05020498, AA3-05020501, AA3-05020509, AA3-05020510, AA3-05020515, AA3-8C003854, AA3-01012358, AA3-01012361, AA3-05020290, AA3-06023726, AA3-06023734, AA3-06023740, AA3-06023741, AA3-96007589, AA3-97008502, AA3-97008504, AA3-97008505, AA3-97008506, AA3-97008513, AA3-97008517, AA3-97008522, AA3-97008523, AA3-97008524, AA3-97008526, AA3-97008529, AA3-01012354, AA3-8C003941, AA3-03014234, AA3-9C011990, AA3-06023738, AA3-06024144, AA3-8C003847, AA3-8C003851, AA3-8C003860, AA3-8C003914, AA3-03013810, AA3-03013814, AA3-03013815, AA3-03013816, AA3-03013818, AA3-03013821, AA3-03013822, AA3-03013824, AA3-03013825, AA3-03013826, AA3-03013831, AA3-03013835, AA3-03013837, AA3-03013839, AA3-03013841, AA3-03013843, AA3-03013845, AA3-03013846, AA3-03013903, AA3-03013906, AA3-03013907, AA3-03013908, AA3-03013909, AA3-03013912, AA3-03013913, AA3-03013915, AA3-03013922, AA3-03014227, AA3-03014228, AA3-03014229, AA3-03014230, AA3-03014231, AA3-03014232, AA3-03014233, AA3-03014235, AA3-03014236, AA3-03014520, AA3-03014521, AA3-03014522, AA3-03014523, AA3-03014524, AA3-03014525, AA3-03014526, AA3-03014527, AA3-03014528, AA3-03014529, AA3-03014530, AA3-03014532, AA3-03014533, AA3-03014534, AA3-03014535, AA3-03014536, AA3-03014537, AA3-03014539, AA3-03014540, AA3-03014541, AA3-03014542, AA3-03014543, AA3-03014544, AA3-03014545, AA3-03014546, AA3-03014547, AA3-9C011974, AA3-9C011978, AA3-9C011980, AA3-9C011981, AA3-9C011987, AA3-9C012048, AA3-9C012051, AA3-9C012052, AA3-9C012059, AA3-97008339, AA3-97008351, AA3-04016714, AA3-05020291, AA3-05020292, AA3-05020293, AA3-05020294, AA3-06024141, AA3-06024147, AA3-06024148, AA3-06024151, AA3-06024158, AA3-06024159, AA3-06024163, AA3-06024165, AA3-05021395, AA3-05021400, AA3-05021437, AA3-05021441, AA3-06024137, AA3-06024142, AA3-06024154, AA3-06024155, AA3-06024157, AA3-06024162, AA3-06024166, AA3-05021397, AA3-05021421, AA3-05021442, AA3-06024132, AA3-06024136, AA3-06024138, AA3-06024139, AA3-06024145, AA3-06024152, AA3-03013811, AA3-03013813, AA3-03013819, AA3-03013823, AA3-03013827, AA3-03013834, AA3-03013836, AA3-03013844, AA3-03013904, AA3-03013918, AA3-03013919, AA3-03013921, AA3-03014548, AA3-03014549, AA3-9C011977, AA3-9C011983, AA3-9C011984, AA3-9C011988, AA3-9C011989, AA3-9C012053, AA3-9C012055, AA3-9C012056, AA3-9C012057, AA3-9C012062, AA3-9C012063, AA3-04015262, AA3-04015244, AA3-04015245, AA3-04015246, AA3-04015247, AA3-04015248, AA3-04015249, AA3-04015250, AA3-04015251, AA3-04015252, AA3-04015253, AA3-04015254, AA3-04015255, AA3-04015256, AA3-04015257, AA3-04015258, AA3-04015260, AA3-04015261, AA3-04015264, AA3-04015265, AA3-04015266, AA3-04015267, AA3-04015268, AA3-04015269, AA3-04015270, AA3-04015271, AA3-04015272, AA3-04015273, AA3-04015274, AA3-04015275, AA3-04015276, AA3-04015277, AA3-04015278, AA3-04015279, AA3-04015280, AA3-04015281, AA3-04015282, AA3-04015283, AA3-04015284, AA3-04015287, AA3-04015288, AA3-04015289, AA3-04015290, AA3-04015291, AA3-04015292, AA3-0401 …
Serial #
AA3-8C003845. Q6660E-PA00018: 13. N1 Masimo, CO2:
Part / Item #
6660E-PA00019
Serial #
AA3-04017986, AA3-8C003800, AA3-8C003796, AA3-8C003799, AA3-8C003806, AA3-8C003808, AA3-8C003811, AA3-8C003801. 14. N1 Masimo, ST, CO2:
Part / Item #
6660E-PA00020
Serial #
AA3-8C003812, AA3-8C003818, AA3-04017995, AA3-04017996, AA3-06023744, AA3-8C003797 — +12 moreShow all
AA3-8C003812, AA3-8C003818, AA3-04017995, AA3-04017996, AA3-06023744, AA3-8C003797, AA3-8C003813, AA3-8C003821, AA3-8C003802, AA3-8C003805, AA3-8C003809, AA3-8C003814, AA3-8C003816, AA3-8C003817, AA3-8C003819. 15. N1 Masimo, ST, Glasgow, CO2:
Part / Item #
6660E-PA00021
Serial #
AA3-94005944, AA3-06024119, AA3-06024128, AA3-06024130, AA3-06023784, AA3-94006095 — +63 moreShow all
AA3-94005944, AA3-06024119, AA3-06024128, AA3-06024130, AA3-06023784, AA3-94006095, AA3-94006108, AA3-94006109, AA3-94006116, AA3-06023790, AA3-06023791, AA3-06023792, AA3-06023793, AA3-06023798, AA3-06023799, AA3-06023801, AA3-06023802, AA3-06023803, AA3-06023806, AA3-06023809, AA3-07024373, AA3-07024374, AA3-07024375, AA3-07024377, AA3-07024380, AA3-07024381, AA3-07024382, AA3-07024383, AA3-07024385, AA3-07024387, AA3-07024389, AA3-06023795, AA3-06023796, AA3-06023797, AA3-06023800, AA3-06023807, AA3-07024378, AA3-07024386, AA3-07024390, AA3-92004699, AA3-94006093, AA3-94006100, AA3-94006104, AA3-94006106, AA3-94006112, AA3-06024118, AA3-06024121, AA3-06024122, AA3-06024123, AA3-06024124, AA3-06024127, AA3-07024384, AA3-92004701, AA3-92004705, AA3-94005932, AA3-94006090, AA3-94006091, AA3-94006097, AA3-94006102, AA3-94006103, AA3-94006107, AA3-94006110, AA3-94006111, AA3-94006113, AA3-94006117, AA3-94006120. 16. Used N1 Masimo, ST, Glasgow, CO2:
Part / Item #
Numb
Additional code information

er: Q6660E-PA00021; Serial Numbers: AA3-91004097, AA3-91004199, AA3-91004200, AA3-91004208. Canadian Configurations 1. N1, Masimo, ST, Glasgow, CO2: Part Number: 6660E-PA00021, Serial Numbers: AA3-91004203. Quantity: 1. 2. N1, Nellcor/Canada: Part Number: 6660E-PA00030, Serial Numbers: AA3-03014709, AA3-03014852. Quantity: 2. 3. N1, Nellcor, ST/Canada: Part Number: 6660E-PA00031, Serial Numbers: AA3-9C011897, AA3-9C011898, AA3-9C011899, AA3-9C011903, AA3-9C011904, AA3-9C011906, AA3-9C011908, AA3-9C011909, AA3-9C011912, AA3-9C011913. Quantity: 10. 4. N1, Nellcor, ST, Glasgow/Canada: Part Number: 6660E-PA00032, Serial Numbers: AA3-9C011272, AA3-9C011273. Quantity: 2. 5. N1,Nellcor,ST,Glasgow,CO2,BOA/Canada: Part Number: 6660E-PA00035, Serial Numbers: AA3-8C003787, AA3-8C003794, AA3-8C003795. Quantity: 3. 6. N1, Masimo, ST, Glasgow, CO2,BOA/Canada: Part Number: 6660E-PA00041, Serial Numbers: AA3-06023770, AA3-06023771, AA3-06023772, AA3-06023773, AA3-06023774, AA3-06023775, AA3-06023776, AA3-06023777, AA3-06023778, AA3-06023780, AA3-06023781, AA3-06023783, AA3-06023786, AA3-06023787, AA3-06023788, AA3-06023789, AA3-94006098, AA3-94006105. Quantity: 18.

What the firm is doing

Mindray contacted consignees via letter on about 08/15/2025. consignees were instructed that they may continue to use the BeneVision N1 patient monitor as a multi-parameter module with Mindray host monitors. Per the additional guidance, it is recommended to confirm that the remaining alarm time counter is actively displayed and follows the existing N1 Operator's Manual: Instructions for when the Alarm Pause is Activated. An image was also included in the notification letter showing the correctly displayed Alarm Pause notification and timer. Consignees were also requested to make all applicable clinical staff aware of the issue and to complete and return the Acknowledgement and Receipt form. Mindray's Care team will deploy a software update to correct the issue. Distributors were advised to contact their direct customers and notify them directly.

DistributionShow details

Worldwide - Nationwide distribution and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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