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RecallWatchMedical Device Safety
Class IIOngoingZ-2259-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura system

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported Jun 3, 2026 · 1 month ago
Legal News Analyst ·

Reason for recall

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

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.

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

Lot / code information

Model
722003
UDI
N/A
Serial #
445, 1555, 1114, 1529, 472, 1349 — +74 moreShow all
445, 1555, 1114, 1529, 472, 1349, 1594, 1311, 1472, 1187, 1700, 1031, 912, 913, 940, 285, 1637, 5, 797, 639, 452, 1585, 535, 1338, 1641, 1916, 614, 605, 492, 1612, 505, 239, 1216, 1169, 1118, 115, 519, 356, 715, 423, 1399, 789, 1509, 1016, 875, 1923, 313, 314, 1919, 1458, 369, 1176, 1230, 1925, 339, 1325, 1633, 596, 1784, 464, 796, 1928, 1025, 292, 1669, 1697, 708, 1, 1760, 1452, 346, 961, 1172, 354, 416, 363, 582, 161, 569, 922; 2. Allura Xper FD10
Model
722010
UDI
(01)00884838059030(21)1123, (01)00884838059030(21)932, (01)00884838059030(21)239, (01)00884838059030(21)360, (01)00884838059030(21)500, (01)00884838059030(21)794 — +727 moreShow all
(01)00884838059030(21)1123, (01)00884838059030(21)932, (01)00884838059030(21)239, (01)00884838059030(21)360, (01)00884838059030(21)500, (01)00884838059030(21)794, (01)00884838059030(21)939, (01)00884838059030(21)921, (01)00884838059030(21)286, (01)00884838059030(21)1440, (01)00884838059030(21)1144, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)107, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)656, (01)00884838059030(21)1261, (01)00884838059030(21)1170, (01)00884838059030(21)585, (01)00884838059030(21)1128, (01)00884838059030(21)882, (01)00884838059030(21)1230, (01)00884838059030(21)280, (01)00884838059030(21)488, (01)00884838059030(21)787, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)190, (01)00884838059030(21)1181, (01)00884838059030(21)694, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)1149, (01)00884838059030(21)423, (01)00884838059030(21)1176, (01)00884838059030(21)1173, (01)00884838059030(21)1040, (01)00884838059030(21)1309, (01)00884838059030(21)763, (01)00884838059030(21)931, (01)00884838059030(21)478, (01)00884838059030(21)1298, (01)00884838059030(21)970, (01)00884838059030(21)1226, (01)00884838059030(21)290, (01)00884838059030(21)365, (01)00884838059030(21)651, (01)00884838059030(21)1292, (01)00884838059030(21)1275, (01)00884838059030(21)755, (01)00884838059030(21)671, (01)00884838059030(21)677, (01)00884838059030(21)1336, (01)00884838059030(21)477, (01)00884838059030(21)1078, (01)00884838059030(21)467, (01)00884838059030(21)1369, (01)00884838059030(21)792, (01)00884838059030(21)679, (01)00884838059030(21)485, (01)00884838059030(21)395, (01)00884838059030(21)592, (01)00884838059030(21)1312, (01)00884838059030(21)1302, (01)00884838059030(21)505, (01)00884838059030(21)714, (01)00884838059030(21)414, (01)00884838059030(21)785, (01)00884838059030(21)1283, (01)00884838059030(21)119, (01)00884838059030(21)662, (01)00884838059030(21)698, (01)00884838059030(21)690, (01)00884838059030(21)1235, (01)00884838059030(21)1233, (01)00884838059030(21)1236, (01)00884838059030(21)1234, (01)00884838059030(21)158, (01)00884838059030(21)1009, (01)00884838059030(21)992, (01)00884838059030(21)1214, (01)00884838059030(21)1064, (01)00884838059030(21)979, (01)00884838059030(21)764, (01)00884838059030(21)920, (01)00884838059030(21)788, (01)00884838059030(21)1396, (01)00884838059030(21)902, (01)00884838059030(21)1344, (01)00884838059030(21)1183, (01)00884838059030(21)453, (01)00884838059030(21)1118, (01)00884838059030(21)411, (01)00884838059030(21)1210, (01)00884838059030(21)1209, (01)00884838059030(21)1041, (01)00884838059030(21)1042, (01)00884838059030(21)1432, (01)00884838059030(21)308, (01)00884838059030(21)833, (01)00884838059030(21)1310, (01)00884838059030(21)728, (01)00884838059030(21)791, (01)00884838059030(21)480, (01)00884838059030(21)1263, (01)00884838059030(21)987, (01)00884838059030(21)986, (01)00884838059030(21)422, (01)00884838059030(21)905, (01)00884838059030(21)218, (01)00884838059030(21)1005, (01)00884838059030(21)1425, (01)00884838059030(21)1397, (01)00884838059030(21)1398, (01)00884838059030(21)1132, (01)00884838059030(21)468, (01)00884838059030(21)1442, (01)00884838059030(21)1048, (01)00884838059030(21)648, (01)00884838059030(21)646, (01)00884838059030(21)1126, (01)00884838059030(21)873, (01)00884838059030(21)252, (01)00884838059030(21)343, (01)00884838059030(21)1011, (01)00884838059030(21)1370, (01)00884838059030(21)838, (01)00884838059030(21)1391, (01)00884838059030(21)999, (01)00884838059030(21)285, (01)00884838059030(21)636, (01)00884838059030(21)624, (01)00884838059030(21)241, (01)00884838059030(21)1084, (01)00884838059030(21)896, (01)00884838059030(21)673, (01)00884838059030(21)683, (01)00884838059030(21)1441, (01)00884838059030(21)914, (01)00884838059030(21)531, (01)00884838059030(21)818, (01)00884838059030(21)1395, (01)00884838059030(21)637, (01)00884838059030(21)917, (01)00884838059030(21)214, (01)00884838059030(21)1043, (01)00884838059030(21)1365, (01)00884838059030(21)1109, (01)00884838059030(21)1297, (01)00884838059030(21)572, (01)00884838059030(21)1436, (01)00884838059030(21)638, (01)00884838059030(21)1112, (01)00884838059030(21)1373, (01)00884838059030(21)946, (01)00884838059030(21)878, (01)00884838059030(21)1108, (01)00884838059030(21)809, (01)00884838059030(21)830, (01)00884838059030(21)839, (01)00884838059030(21)1069, (01)00884838059030(21)1287, (01)00884838059030(21)1308, (01)00884838059030(21)1424, (01)00884838059030(21)604, (01)00884838059030(21)605, (01)00884838059030(21)777, (01)00884838059030(21)666, (01)00884838059030(21)654, (01)00884838059030(21)1122, (01)00884838059030(21)601, (01)00884838059030(21)301, (01)00884838059030(21)426, (01)00884838059030(21)924, (01)00884838059030(21)1198, (01)00884838059030(21)577, (01)00884838059030(21)1047, (01)00884838059030(21)1187, (01)00884838059030(21)447, (01)00884838059030(21)1250, (01)00884838059030(21)1147, (01)00884838059030(21)1034, (01)00884838059030(21)1421, (01)00884838059030(21)1258, (01)00884838059030(21)652, (01)00884838059030(21)1016, (01)00884838059030(21)1015, (01)00884838059030(21)1017, (01)00884838059030(21)1018, (01)00884838059030(21)1423, (01)00884838059030(21)1332, (01)00884838059030(21)1106, (01)00884838059030(21)980, (01)00884838059030(21)1169, (01)00884838059030(21)1438, (01)00884838059030(21)868, (01)00884838059030(21)383, (01)00884838059030(21)782, (01)00884838059030(21)125, (01)00884838059030(21)697, (01)00884838059030(21)523, (01)00884838059030(21)708, (01)00884838059030(21)707, (01)00884838059030(21)594, (01)00884838059030(21)1267, (01)00884838059030(21)891, (01)00884838059030(21)1146, (01)00884838059030(21)566, (01)00884838059030(21)861, (01)00884838059030(21)1321, (01)00884838059030(21)1096, (01)00884838059030(21)906, (01)00884838059030(21)1366, (01)00884838059030(21)374, (01)00884838059030(21)1363, (01)00884838059030(21)243, (01)00884838059030(21) …
Model
722026
UDI
(01)00884838054189(21)683, (01)00884838054189(21)155, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054189(21)786 — +435 moreShow all
(01)00884838054189(21)683, (01)00884838054189(21)155, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054189(21)786, (01)00884838054189(21)654, (01)00884838054189(21)1132, (01)00884838054189(21)458, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054189(21)436, (01)00884838054189(21)1338, (01)00884838054189(21)1068, (01)00884838054189(21)233, (01)00884838054189(21)78, (01)00884838054189(21)432, (01)00884838054189(21)224, (01)00884838054189(21)1072, (01)00884838054189(21)93, (01)00884838054189(21)796, (01)00884838054189(21)543, (01)00884838054189(21)1248, (01)00884838054189(21)561, (01)00884838054189(21)1129, (01)00884838054189(21)781, (01)00884838054189(21)344, (01)00884838054189(21)374, (01)00884838054189(21)634, (01)00884838054189(21)908, (01)00884838054189(21)130, (01)00884838054189(21)370, (01)00884838054189(21)235, (01)00884838054189(21)190, (01)00884838054189(21)259, (01)00884838054189(21)324, (01)00884838054189(21)969, (01)00884838054189(21)323, (01)00884838054189(21)98, (01)00884838054189(21)99, (01)00884838054189(21)100, (01)00884838054189(21)142, (01)00884838054189(21)1246, (01)00884838054189(21)601, (01)00884838054189(21)877, (01)00884838054189(21)221, (01)00884838054189(21)204, (01)00884838054189(21)843, (01)00884838054189(21)1231, (01)00884838054189(21)1038, (01)00884838054189(21)114, (01)00884838054189(21)1287, (01)00884838054189(21)878, (01)00884838054189(21)558, (01)00884838054189(21)391, (01)00884838054189(21)389, (01)00884838054189(21)633, (01)00884838054189(21)1050, (01)00884838054189(21)1000, (01)00884838054189(21)909, (01)00884838054189(21)600, (01)00884838054189(21)841, (01)00884838054189(21)185, (01)00884838054189(21)713, (01)00884838054189(21)394, (01)00884838054189(21)731, (01)00884838054189(21)75, (01)00884838054189(21)646, (01)00884838054189(21)728, (01)00884838054189(21)223, (01)00884838054189(21)765, (01)00884838054189(21)192, (01)00884838054189(21)959, (01)00884838054189(21)825, (01)00884838054189(21)942, (01)00884838054189(21)1192, (01)00884838054189(21)990, (01)00884838054189(21)381, (01)00884838054189(21)774, (01)00884838054189(21)368, (01)00884838054189(21)245, (01)00884838054189(21)485, (01)00884838054189(21)484, (01)00884838054189(21)648, (01)00884838054189(21)966, (01)00884838054189(21)1268, (01)00884838054189(21)109, (01)00884838054189(21)110, (01)00884838054189(21)116, (01)00884838054189(21)604, (01)00884838054189(21)627, (01)00884838054189(21)319, (01)00884838054189(21)716, (01)00884838054189(21)396, (01)00884838054189(21)531, (01)00884838054189(21)156, (01)00884838054189(21)253, (01)00884838054189(21)965, (01)00884838054189(21)444, (01)00884838054189(21)1189, (01)00884838054189(21)1126, (01)00884838054189(21)1210, (01)00884838054189(21)1239, (01)00884838054189(21)102, (01)00884838054189(21)1215, (01)00884838054189(21)696, (01)00884838054189(21)560, (01)00884838054189(21)297, (01)00884838054189(21)562, (01)00884838054189(21)11, (01)00884838054189(21)832, (01)00884838054189(21)335, (01)00884838054189(21)664, (01)00884838054189(21)845, (01)00884838054189(21)778, (01)00884838054189(21)215, (01)00884838054189(21)935, (01)00884838054189(21)782, (01)00884838054189(21)614, (01)00884838054189(21)222, (01)00884838054189(21)205, (01)00884838054189(21)284, (01)00884838054189(21)115, (01)00884838054189(21)694, (01)00884838054189(21)74, (01)00884838054189(21)838, (01)00884838054189(21)244, (01)00884838054189(21)973, (01)00884838054189(21)985, (01)00884838054189(21)101, (01)00884838054189(21)855, (01)00884838054189(21)287, (01)00884838054189(21)378, (01)00884838054189(21)612, (01)00884838054189(21)725, (01)00884838054189(21)914, (01)00884838054189(21)805, (01)00884838054189(21)622, (01)00884838054189(21)234, (01)00884838054189(21)1293, (01)00884838054189(21)121, (01)00884838054189(21)512, (01)00884838054189(21)559, (01)00884838054189(21)1205, (01)00884838054189(21)79, (01)00884838054189(21)617, (01)00884838054189(21)1101, (01)00884838054189(21)738, (01)00884838054189(21)957, (01)00884838054189(21)431, (01)00884838054189(21)201, (01)00884838054189(21)1340, (01)00884838054189(21)122, (01)00884838054189(21)663, (01)00884838054189(21)653, (01)00884838054189(21)688, (01)00884838054189(21)563, (01)00884838054189(21)704, (01)00884838054189(21)462, (01)00884838054189(21)191, (01)00884838054189(21)931, (01)00884838054189(21)967, (01)00884838054189(21)265, (01)00884838054189(21)998, (01)00884838054189(21)986, (01)00884838054189(21)534, (01)00884838054189(21)807, (01)00884838054189(21)962, (01)00884838054189(21)961, (01)00884838054189(21)1049, (01)00884838054189(21)707, (01)00884838054189(21)866, (01)00884838054189(21)1115, (01)00884838054189(21)759, (01)00884838054189(21)830, (01)00884838054189(21)638, (01)00884838054189(21)271, (01)00884838054189(21)813, (01)00884838054189(21)775, (01)00884838054189(21)1316, (01)00884838054189(21)343, (01)00884838054189(21)406, (01)00884838054189(21)252, (01)00884838054189(21)748, (01)00884838054189(21)616, (01)00884838054189(21)1278, (01)00884838054189(21)1104, (01)00884838054189(21)446, (01)00884838054189(21)557, (01)00884838054189(21)1368, (01)00884838054189(21)358, (01)00884838054189(21)310, (01)00884838054189(21)497, (01)00884838054189(21)977, (01)00884838054189(21)471, (01)00884838054189(21)334, (01)00884838054189(21)65, (01)00884838054189(21)461, (01)00884838054189(21)1001, (01)00884838054189(21)806, (01)00884838054189(21)769, (01)00884838054189(21)143, (01)00884838054189(21)711, (01)00884838054189(21)257, (01)00884838054189(21)881, (01)00884838054189(21)581, (01)00884838054189(21)576, (01)00884838054189(21)1127, (01)00884838054189(21)1128, (01)00884838054189(21)1258, (01)00884838054189(21)1307, (01)00884838054189(21)311, (01)00884838054189(21)90, (01)00884838054189(21)1092, (01)00884838054189(21)276, (01)00884838054189(21)722, (01)00884838054189(21)1188, (01)00884838054189(21)809, (01)00884838054189(21)1326, (01)00884838054189(21)1067, (01)00884838054189(21)404, (0 …
Additional code information

189(21)656, (01)00884838054189(21)857, (01)00884838054189(21)803, (01)00884838054189(21)585, (01)00884838054189(21)854, (01)00884838054189(21)382, (01)00884838054189(21)779, (01)00884838054189(21)632, (01)00884838054189(21)1165, (01)00884838054189(21)183, (01)00884838054189(21)418, (01)00884838054189(21)28, (01)00884838054189(21)342, (01)00884838054189(21)403, (01)00884838054189(21)511, (01)00884838054189(21)209, (01)00884838054189(21)330, (01)00884838054189(21)1218, (01)00884838054189(21)91, (01)00884838054189(21)71, (01)00884838054189(21)525, (01)00884838054189(21)1327, (01)00884838054189(21)490, (01)00884838054189(21)730, (01)00884838054189(21)941, (01)00884838054189(21)1286, (01)00884838054189(21)416, (01)00884838054189(21)915, (01)00884838054189(21)303, (01)00884838054189(21)526, (01)00884838054189(21)1229, (01)00884838054189(21)643, (01)00884838054189(21)125, (01)00884838054189(21)726, (01)00884838054189(21)505, (01)00884838054189(21)846, (01)00884838054189(21)637, 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What the firm is doing

On April 30, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this URGENT Medical Device Correction letter to all users of the system so that they are aware of the issue. 2. In case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available. 3. In case the affected system has been transferred to another organization, please send a copy of this URGENT Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 4. Keep this URGENT Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 5. If you experience the issue described in this letter, please report it to your local Philips representative. Actions by Philips: Philips will replace the HDDs in all affected systems. Philips expects to start replacing the HDDs in September 2026. A local Philips representative will contact you to schedule a visit to replace the HDDs in your system.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussal, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, 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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