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RecallWatchMedical Device Safety
Class IIOngoingZ-1091-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the follow…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported Jan 21, 2026 · 5 months ago
Legal News Analyst ·

Reason for recall

Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.

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.

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

Lot / code information

UDI
): 722063 ((01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132 — +267 moreShow all
): 722063 ((01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)108, (01)00884838085275(21)153, (01)00884838085275(21)69, (01)00884838085275(21)154, (01)00884838085275(21)97, (01)00884838085275(21)137, (01)00884838085275(21)116, (01)00884838085275(21)127, (01)00884838085275(21)151, (01)00884838085275(21)148, (01)00884838085275(21)150, (01)00884838085275(21)146, (01)00884838085275(21)149, (01)00884838085275(21)123, (01)00884838085275(21)130, (01)00884838085275(21)143, (01)00884838085275(21)139, (01)00884838085275(21)144, (01)00884838085275(21)145, (01)00884838085275(21)141, (01)00884838085275(21)140, (01)00884838085275(21)135, (01)00884838085275(21)133, (01)00884838085275(21)107, (01)00884838085275(21)120, (01)00884838085275(21)129, (01)00884838085275(21)105, (01)00884838085275(21)110, (01)00884838085275(21)128, (01)00884838085275(21)119, (01)00884838085275(21)113, (01)00884838085275(21)43, (01)00884838085275(21)117, (01)00884838085275(21)115, (01)00884838085275(21)101, (01)00884838085275(21)94, (01)00884838085275(21)106, (01)00884838085275(21)103, (01)00884838085275(21)99, (01)00884838085275(21)102, (01)00884838085275(21)104, (01)00884838085275(21)100, (01)00884838085275(21)80, (01)00884838085275(21)81, (01)00884838085275(21)89, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)82, (01)00884838085275(21)87, (01)00884838085275(21)93, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)79, (01)00884838085275(21)83, (01)00884838085275(21)76, (01)00884838085275(21)77, (01)00884838085275(21)78, (01)00884838085275(21)70, (01)00884838085275(21)53, (01)00884838085275(21)72, (01)00884838085275(21)63, (01)00884838085275(21)71, (01)00884838085275(21)73, (01)00884838085275(21)62, (01)00884838085275(21)50, (01)00884838085275(21)59, (01)00884838085275(21)54, (01)00884838085275(21)61, (01)00884838085275(21)52, (01)00884838085275(21)55, (01)00884838085275(21)40, (01)00884838085275(21)51, (01)00884838085275(21)48, (01)00884838085275(21)47, (01)00884838085275(21)46, (01)00884838085275(21)44, (01)00884838085275(21)41, (01)00884838085275(21)38, (01)00884838085275(21)29, (01)00884838085275(21)27, (01)00884838085275(21)28, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)26, (01)00884838085275(21)25, (01)00884838085275(21)30, (01)00884838085275(21)21, (01)00884838085275(21)24, (01)00884838085275(21)22, (01)00884838085275(21)19, (01)00884838085275(21)23, (01)00884838085275(21)18, (01)00884838085275(21)17, (01)00884838085275(21)15, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)3, (01)00884838085275(21)2, (01)00884838085275(21)4, (01)00884838085275(21)121), 722221 ((01)00884838099203(21)181, (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838099203(21)178, (01)00884838099203(21)54, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)177, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)171, (01)00884838099203(21)153, (01)00884838099203(21)108, (01)00884838099203(21)207, (01)00884838099203(21)208, (01)00884838099203(21)198, (01)00884838099203(21)193, (01)00884838099203(21)194, (01)00884838099203(21)205, (01)00884838099203(21)203, (01)00884838099203(21)202, (01)00884838099203(21)195, (01)00884838099203(21)196, (01)00884838099203(21)197, (01)00884838099203(21)190, (01)00884838099203(21)146, (01)00884838099203(21)186, (01)00884838099203(21)35, (01)00884838099203(21)43, (01)00884838099203(21)180, (01)00884838099203(21)187, (01)00884838099203(21)182, (01)00884838099203(21)185, (01)00884838099203(21)173, (01)00884838099203(21)183, (01)00884838099203(21)164, (01)00884838099203(21)184, (01)00884838099203(21)165, (01)00884838099203(21)176, (01)00884838099203(21)174, (01)00884838099203(21)159, (01)00884838099203(21)161, (01)00884838099203(21)157, (01)00884838099203(21)169, (01)00884838099203(21)162, (01)00884838099203(21)167, (01)00884838099203(21)168, (01)00884838099203(21)142, (01)00884838099203(21)145, (01)00884838099203(21)158, (01)00884838099203(21)166, (01)00884838099203(21)163, (01)00884838099203(21)149, (01)00884838099203(21)126, (01)00884838099203(21)154, (01)00884838099203(21)151, (01)00884838099203(21)127, (01)00884838099203(21)152, (01)00884838099203(21)155, (01)00884838099203(21)131, (01)00884838099203(21)147, (01)00884838099203(21)129, (01)00884838099203(21)122, (01)00884838099203(21)133, (01)00884838099203(21)144, (01)00884838099203(21)130, (01)00884838099203(21)143, (01)00884838099203(21)135, (01)00884838099203(21)140, (01)00884838099203(21)141, (01)00884838099203(21)128, (01)00884838099203(21)134, (01)00884838099203(21)132, (01)00884838099203(21)123, (01)00884838099203(21)118, (01)00884838099203(21)96, (01)00884838099203(21)120, (01)00884838099203(21)86, (01)00884838099203(21)124, (01)00884838099203(21)119, (01)00884838099203(21)107, (01)00884838099203(21)114, (01)00884838099203(21)98, (01)00884838099203(21)103, (01)00884838099203(21)74, (01)00884838099203(21)99, (01)00884838099203(21)81, (01)00884838099203(21)104, (01)00884838099203(21)106, (01)00884838099203(21)95, (01)00884838099203(21)102, (01)00884838099203(21)78, (01)00884838099203(21)97, (01)00884838099203(21)91, (01)00884838099203(21)66, (01)00884838099203(21)105, (01)00884838099203(21)101, (01)00884838099203(21)94, (01)00884838099203(21)52, (01)00884838099203(21)83, (01)00884838099203(21)84, (01)00884838099203(21)82, (01)00884838099203(21)64, (01)00884838099203(21)92, (01)00884838099203(21)55, (01)00884838099203(21)62, (01)00884838099203(21)79, (01)00884838099203(21)61, (01)00884838099203(21)71, (01)00884838099203(21)67, (01)00884838099203 …
UDI
): 722064 ((01)00884838085282(21)209, (01)00884838085282(21)238, (01)00884838085282(21)201, (01)00884838085282(21)258, (01)00884838085282(21)261, (01)00884838085282(21)260 — +764 moreShow all
): 722064 ((01)00884838085282(21)209, (01)00884838085282(21)238, (01)00884838085282(21)201, (01)00884838085282(21)258, (01)00884838085282(21)261, (01)00884838085282(21)260, (01)00884838085282(21)314, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)267, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)407, (01)00884838085282(21)496, (01)00884838085282(21)425, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)397, (01)00884838085282(21)168, (01)00884838085282(21)514, (01)00884838085282(21)503, (01)00884838085282(21)517, (01)00884838085282(21)515, (01)00884838085282(21)478, (01)00884838085282(21)484, (01)00884838085282(21)511, (01)00884838085282(21)458, (01)00884838085282(21)513, (01)00884838085282(21)505, (01)00884838085282(21)502, (01)00884838085282(21)510, (01)00884838085282(21)508, (01)00884838085282(21)470, (01)00884838085282(21)509, (01)00884838085282(21)494, (01)00884838085282(21)497, (01)00884838085282(21)477, (01)00884838085282(21)445, (01)00884838085282(21)448, (01)00884838085282(21)500, (01)00884838085282(21)501, (01)00884838085282(21)471, (01)00884838085282(21)491, (01)00884838085282(21)498, (01)00884838085282(21)490, (01)00884838085282(21)475, (01)00884838085282(21)480, (01)00884838085282(21)504, (01)00884838085282(21)479, (01)00884838085282(21)488, (01)00884838085282(21)395, (01)00884838085282(21)485, (01)00884838085282(21)474, (01)00884838085282(21)476, (01)00884838085282(21)483, (01)00884838085282(21)468, (01)00884838085282(21)492, (01)00884838085282(21)473, (01)00884838085282(21)472, (01)00884838085282(21)467, (01)00884838085282(21)461, (01)00884838085282(21)469, (01)00884838085282(21)462, (01)00884838085282(21)446, (01)00884838085282(21)463, (01)00884838085282(21)447, (01)00884838085282(21)451, (01)00884838085282(21)454, (01)00884838085282(21)457, (01)00884838085282(21)427, (01)00884838085282(21)345, (01)00884838085282(21)452, (01)00884838085282(21)449, (01)00884838085282(21)416, (01)00884838085282(21)444, (01)00884838085282(21)442, (01)00884838085282(21)431, (01)00884838085282(21)439, (01)00884838085282(21)421, (01)00884838085282(21)441, (01)00884838085282(21)440, (01)00884838085282(21)437, (01)00884838085282(21)443, (01)00884838085282(21)426, (01)00884838085282(21)400, (01)00884838085282(21)429, (01)00884838085282(21)419, (01)00884838085282(21)432, (01)00884838085282(21)434, (01)00884838085282(21)324, (01)00884838085282(21)330, (01)00884838085282(21)408, (01)00884838085282(21)401, (01)00884838085282(21)414, (01)00884838085282(21)394, (01)00884838085282(21)404, (01)00884838085282(21)422, (01)00884838085282(21)412, (01)00884838085282(21)344, (01)00884838085282(21)413, (01)00884838085282(21)304, (01)00884838085282(21)343, (01)00884838085282(21)245, (01)00884838085282(21)310, (01)00884838085282(21)389, (01)00884838085282(21)405, (01)00884838085282(21)322, (01)00884838085282(21)406, 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(01)00884838085282(21)313, (01)00884838085282(21)251, (01)00884838085282(21)309, (01)00884838085282(21)306, (01)00884838085282(21)303, (01)00884838085282(21)278, (01)00884838085282(21)302, (01)00884838085282(21)294, (01)00884838085282(21)276, (01)00884838085282(21)297, (01)00884838085282(21)296, (01)00884838085282(21)295, (01)00884838085282(21)293, (01)00884838085282(21)292, (01)00884838085282(21)290, (01)00884838085282(21)288, (01)00884838085282(21)289, (01)00884838085282(21)249, (01)00884838085282(21)287, (01)00884838085282(21)282, (01)00884838085282(21)228, (01)00884838085282(21)284, (01)00884838085282(21)285, (01)00884838085282(21)272, (01)00884838085282(21)254, (01)00884838085282(21)280, (01)00884838085282(21)283, (01)00884838085282(21)274, (01)00884838085282(21)256, (01)00884838085282(21)275, (01)00884838085282(21)269, (01)00884838085282(21)265, (01)00884838085282(21)277, (01)00884838085282(21)266, (01)00884838085282(21)271, (01)00884838085282(21)247, (01)00884838085282(21)236, (01)00884838085282(21)268, (01)00884838085282(21)262, (01)00884838085282(21)263, (01)00884838085282(21)234, (01)00884838085282(21)264, (01)00884838085282(21)246, (01)00884838085282(21)257, (01)00884838085282(21)255, (01)00884838085282(21)231, (01)00884838085282(21)253, (01)00884838085282(21)233, (01)00884838085282(21)252, (01)00884838085282(21)237, (01)00884838085282(21)241, (01)00884838085282(21)225, (01)00884838085282(21)250, (01)00884838085282(21)230, (01)00884838085282(21)235, (01)00884838085282(21)179, (01)00884838085282(21)200, (01)00884838085282(21)198, (01)00884838085282(21)208, (01)00884838085282(21)220, (01)00884838085282(21)186, (01)00884838085282(21)221, (01)00884838085282(21)207, (01)00884838085282(21)215, (01)00884838085282(21)227, (01)00884838085282(21)222, (01)00884838085282(21)199, (01)00884838085282(21)192, (01)00884838085282(21)212, (01)00884838085282(21)197, (01)00884838085282(21)134, (01)00884838085282(21)206, (01)00884838085282(21)210, (01)00884838085282(21)226, (01)00884838085282(21)1 …
UDI
): 722227 ((01)00884838099227(21)265, (01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)276, (01)00884838099227(21)264, (01)00884838099227(21)63 — +164 moreShow all
): 722227 ((01)00884838099227(21)265, (01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)276, (01)00884838099227(21)264, (01)00884838099227(21)63, (01)00884838099227(21)238, (01)00884838099227(21)360, (01)00884838099227(21)322, (01)00884838099227(21)336, (01)00884838099227(21)356, (01)00884838099227(21)353, (01)00884838099227(21)342, (01)00884838099227(21)338, (01)00884838099227(21)345, (01)00884838099227(21)344, (01)00884838099227(21)284, (01)00884838099227(21)326, (01)00884838099227(21)362, (01)00884838099227(21)351, (01)00884838099227(21)208, (01)00884838099227(21)340, (01)00884838099227(21)348, (01)00884838099227(21)352, (01)00884838099227(21)306, (01)00884838099227(21)335, (01)00884838099227(21)332, (01)00884838099227(21)350, (01)00884838099227(21)331, (01)00884838099227(21)355, (01)00884838099227(21)330, (01)00884838099227(21)334, (01)00884838099227(21)346, (01)00884838099227(21)333, (01)00884838099227(21)297, (01)00884838099227(21)339, (01)00884838099227(21)337, (01)00884838099227(21)324, (01)00884838099227(21)321, (01)00884838099227(21)101, (01)00884838099227(21)313, (01)00884838099227(21)89, (01)00884838099227(21)323, (01)00884838099227(21)329, (01)00884838099227(21)318, (01)00884838099227(21)319, (01)00884838099227(21)175, (01)00884838099227(21)311, (01)00884838099227(21)320, (01)00884838099227(21)308, (01)00884838099227(21)301, (01)00884838099227(21)247, (01)00884838099227(21)315, (01)00884838099227(21)305, (01)00884838099227(21)316, (01)00884838099227(21)272, (01)00884838099227(21)286, (01)00884838099227(21)258, (01)00884838099227(21)300, (01)00884838099227(21)307, (01)00884838099227(21)280, (01)00884838099227(21)294, (01)00884838099227(21)178, (01)00884838099227(21)298, (01)00884838099227(21)253, (01)00884838099227(21)309, (01)00884838099227(21)310, (01)00884838099227(21)304, (01)00884838099227(21)293, (01)00884838099227(21)269, (01)00884838099227(21)260, (01)00884838099227(21)292, (01)00884838099227(21)299, (01)00884838099227(21)230, (01)00884838099227(21)252, (01)00884838099227(21)285, (01)00884838099227(21)102, (01)00884838099227(21)287, (01)00884838099227(21)282, (01)00884838099227(21)273, (01)00884838099227(21)251, (01)00884838099227(21)268, (01)00884838099227(21)290, (01)00884838099227(21)206, (01)00884838099227(21)281, (01)00884838099227(21)263, (01)00884838099227(21)262, (01)00884838099227(21)250, (01)00884838099227(21)261, (01)00884838099227(21)270, (01)00884838099227(21)156, (01)00884838099227(21)213, (01)00884838099227(21)245, (01)00884838099227(21)241, (01)00884838099227(21)259, (01)00884838099227(21)228, (01)00884838099227(21)157, (01)00884838099227(21)256, (01)00884838099227(21)249, (01)00884838099227(21)243, (01)00884838099227(21)209, (01)00884838099227(21)180, (01)00884838099227(21)158, (01)00884838099227(21)227, (01)00884838099227(21)176, (01)00884838099227(21)236, (01)00884838099227(21)240, (01)00884838099227(21)233, (01)00884838099227(21)203, (01)00884838099227(21)248, (01)00884838099227(21)217, (01)00884838099227(21)246, (01)00884838099227(21)257, (01)00884838099227(21)242, (01)00884838099227(21)173, (01)00884838099227(21)234, (01)00884838099227(21)231, (01)00884838099227(21)239, (01)00884838099227(21)181, (01)00884838099227(21)216, (01)00884838099227(21)229, (01)00884838099227(21)222, (01)00884838099227(21)211, (01)00884838099227(21)218, (01)00884838099227(21)215, (01)00884838099227(21)219, (01)00884838099227(21)221, (01)00884838099227(21)220, (01)00884838099227(21)188, (01)00884838099227(21)95, (01)00884838099227(21)205, (01)00884838099227(21)87, (01)00884838099227(21)147, (01)00884838099227(21)204, (01)00884838099227(21)200, (01)00884838099227(21)196, (01)00884838099227(21)194, (01)00884838099227(21)210, (01)00884838099227(21)192, (01)00884838099227(21)187, (01)00884838099227(21)177, (01)00884838099227(21)202, (01)00884838099227(21)198, (01)00884838099227(21)195, (01)00884838099227(21)197, (01)00884838099227(21)199, (01)00884838099227(21)151, (01)00884838099227(21)183, (01)00884838099227(21)191, (01)00884838099227(21)174, (01)00884838099227(21)86, (01)00884838099227(21)179, (01)00884838099227(21)146, (01)00884838099227(21)123, (01)00884838099227(21)140, (01)00884838099227(21)184, (01)00884838099227(21)161, (01)00884838099227(21)145, (01)00884838099227(21)153, (01)00884838099227(21)170, (01)00884838099227(21)172, (01)00884838099227(21)168, (01)00884838099227(21)82, (01)00884838099227(21)163, (01)00884838099227(21)154, (01)00884838099227(21)155, (01)00884838099227(21)159, (01)00884838099227(21)167, (01)00884838099227(21)164, (01)0088
Additional code information

4838099227(21)166, (01)00884838099227(21)134, (01)00884838099227(21)143, (01)00884838099227(21)162, (01)00884838099227(21)160, (01)00884838099227(21)30, (01)00884838099227(21)107, (01)00884838099227(21)149, (01)00884838099227(21)148, (01)00884838099227(21)138, (01)00884838099227(21)124, (01)00884838099227(21)120, (01)00884838099227(21)109, (01)00884838099227(21)136, (01)00884838099227(21)125, (01)00884838099227(21)116, (01)00884838099227(21)165, (01)00884838099227(21)130, (01)00884838099227(21)142, (01)00884838099227(21)132, (01)00884838099227(21)131, (01)00884838099227(21)93, (01)00884838099227(21)133, (01)00884838099227(21)122, (01)00884838099227(21)137, (01)00884838099227(21)108, (01)00884838099227(21)106, (01)00884838099227(21)126, (01)00884838099227(21)127, (01)00884838099227(21)128, (01)00884838099227(21)121, (01)00884838099227(21)118, (01)00884838099227(21)141, (01)00884838099227(21)75, (01)00884838099227(21)114, (01)00884838099227(21)113, (01)00884838099227(21)112, (01)00884838099227(21)99, (01)00884838099227(21)111, (01)00884838099227(21)104, (01)00884838099227(21)115, (01)00884838099227(21)71, (01)00884838099227(21)110, (01)00884838099227(21)103, (01)00884838099227(21)100, (01)00884838099227(21)105, (01)00884838099227(21)90, (01)00884838099227(21)94, (01)00884838099227(21)98, (01)00884838099227(21)92, (01)00884838099227(21)96, (01)00884838099227(21)80, (01)00884838099227(21)53, (01)00884838099227(21)25, (01)00884838099227(21)54, (01)00884838099227(21)85, (01)00884838099227(21)12, (01)00884838099227(21)83, (01)00884838099227(21)91, (01)00884838099227(21)84, (01)00884838099227(21)79, (01)00884838099227(21)77, (01)00884838099227(21)81, (01)00884838099227(21)55, (01)00884838099227(21)76, (01)00884838099227(21)59, (01)00884838099227(21)73, (01)00884838099227(21)65, (01)00884838099227(21)64, (01)00884838099227(21)74, (01)00884838099227(21)41, (01)00884838099227(21)69, (01)00884838099227(21)9, (01)00884838099227(21)72, (01)00884838099227(21)67, (01)00884838099227(21)62, (01)00884838099227(21)8, (01)00884838099227(21)60, (01)00884838099227(21)58, (01)00884838099227(21)61, (01)00884838099227(21)56, (01)00884838099227(21)57, (01)00884838099227(21)52, (01)00884838099227(21)28, (01)00884838099227(21)40, (01)00884838099227(21)26, (01)00884838099227(21)48, (01)00884838099227(21)16, (01)00884838099227(21)44, (01)00884838099227(21)29, (01)00884838099227(21)49, (01)00884838099227(21)47, (01)00884838099227(21)38, (01)00884838099227(21)46, (01)00884838099227(21)37, (01)00884838099227(21)43, (01)00884838099227(21)32, (01)00884838099227(21)20, (01)00884838099227(21)36, (01)00884838099227(21)22, (01)00884838099227(21)35, (01)00884838099227(21)24, (01)00884838099227(21)21, (01)00884838099227(21)2, (01)00884838099227(21)5, (01)00884838099227(21)6, (01)00884838099227(21)7, (01)00884838099227(21)13, (01)00884838099227(21)23, (01)00884838099227(21)19, (01)00884838099227(21)31, (01)00884838099227(21)15, (01)00884838099227(21)17, (01)00884838099227(21)18, (01)00884838099227(21)14, (01)00884838099227(21)4, (01)00884838099227(21)1, (01)00884838099227(21)3, (01)00884838099227(21)11, (01)00884838099227(21)226, (01)00884838099227(21)171). 4. Model Number (UDI): 722228 ((01)00884838099234(21)67, (01)00884838099234(21)524, (01)00884838099234(21)49, (01)00884838099234(21)36, (01)00884838099234(21)10, (01)00884838099234(21)64, (01)00884838099234(21)110, (01)00884838099234(21)403, (01)00884838099234(21)328, (01)00884838099234(21)481, (01)00884838099234(21)373, (01)00884838099234(21)149, (01)00884838099234(21)213, (01)00884838099234(21)45, (01)00884838099234(21)537, (01)00884838099234(21)615, (01)00884838099234(21)159, (01)00884838099234(21)18, (01)00884838099234(21)231, (01)00884838099234(21)180, (01)00884838099234(21)61, (01)00884838099234(21)273, (01)00884838099234(21)204, (01)00884838099234(21)538, (01)00884838099234(21)679, (01)00884838099234(21)678, (01)00884838099234(21)76, (01)00884838099234(21)502, (01)00884838099234(21)150, (01)00884838099234(21)132, (01)00884838099234(21)399, (01)00884838099234(21)533, (01)00884838099234(21)211, (01)00884838099234(21)17, (01)00884838099234(21)47, (01)00884838099234(21)87, 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What the firm is doing

Philips notified consignees on about 12/12/2025 via certified mailing. Consignees were instructed to identify any affected systems on hand, circulate the noification to all users of the system for awareness, notify any recipients if the affected systems have been transferred to another organization, maintain the notification with documentation of the system until Philips completes the correction, and complete and return the response form provided. Philips also provided recommended actions for each issue, if encountered. Philips will address the identified issues by implementing a software update (R2.1.15 or R2.2.15) in all affected systems (FCO72200660 to 2.2.15, FCO72200672 to 2.1.15). Philips expects to have this software update released by Q4 2026 (subject to regulatory clearance). Local Philips representatives will contact each consignee to schedule a visit to install the software updates once available.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine/United Arab Emirate, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Vietnam, Yemen.

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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