CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
Allura Xper FD recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Allura Xper FD, distributed nationwide in the US. The recall was initiated on 29 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2928-2026
- FDA event ID
- 99378
- Recalling firm
- Philips Medical Systems Nederl, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jun 2026
- FDA classified
- 10 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 29 Jun 2026 | Recall initiated by company | |
| 10 Aug 2026 | Classified by FDA | +42 days |
| 19 Aug 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Firmware issue potentially leading to loss of geometry movements.
Product as listed by the FDA
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Vietnam, Yemen.
Questions about this recall
Why was it recalled?
Firmware issue potentially leading to loss of geometry movements.
Which lots are affected?
Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690, (01)00884838054202(21)928, (01)00884838054189(21)155, (01)00884838054202(21)317, (01)00884838054202(21)1774, (01)00884838054202(21)2502, (01)00884838054202(21)869, (01)00884838054202(21)668, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054202(21)406, (01)00884838054202(21)540, (01)00884838054202(21)548, (01)00884838054202(21)1017, (01)00884838054202(21)590, (01)00884838054189(21)654, (01)00884838054189(21)786, (01)00884838054196(21)216, (01)00884838054196(21)230, (01)00884838054202(21)596, (01)00884838054202(21)1957, (01)00884838054202(21)110, (01)00884838054202(21)2261, (01)00884838054189(21)1132, (01)00884838054226(21)115, (01)00884838059115(21)259, (01)00884838054202(21)173, (01)00884838054202(21)866, (01)00884838054202(21)1310, (01)00884838059115(21)203, (01)00884838054202(21)1043, (01)00884838054189(21)458, (01)00884838054202(21)466, (01)00884838054226(21)42, (01)00884838054202(21)1077, (01)00884838059115(21)373, (01)00884838054202(21)877, (01)00884838054202(21)896, (01)00884838054202(21)987, (01)00884838054202(21)995, (01)00884838054202(21)1343, (01)00884838054202(21)1439, (01)00884838059115(21)111, (01)00884838054202(21)895, (01)00884838054202(21)265, (01)00884838054202(21)305, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054196(21)1, (01)00884838054202(21)1154, (01)00884838054196(21)71, (01)00884838054202(21)1000, (01)00884838054202(21)1909, (01)00884838054202(21)121, (01)00884838054189(21)436, (01)00884838054202(21)1716, (01)00884838054202(21)1983, (01)00884838054202(21)784, (01)00884838054202(21)2061, (01)00884838054202(21)729, (01)00884838054189(21)1338, (01)00884838054202(21)1393, (01)00884838054189(21)1068, (01)00884838054189(21)233, (01)00884838054202(21)525, (01)00884838054202(21)1948, (01)00884838054202(21)1656, (01)00884838054189(21)78, (01)00884838054202(21)209, (01)00884838054202(21)825, (01)00884838054202(21)1461, (01)00884838054202(21)408, (01)00884838059115(21)38, (01)00884838054202(21)570, (01)00884838054202(21)218, (01)00884838054202(21)734, (01)00884838054202(21)1050, (01)00884838054202(21)1751, (01)00884838054202(21)454, (01)00884838054202(21)1428, (01)00884838054219(21)57, (01)00884838054189(21)432, (01)00884838054202(21)666, (01)00884838054219(21)7, (01)00884838054189(21)224, (01)00884838054202(21)488, (01)00884838054226(21)108, (01)00884838054202(21)1094, (01)00884838054202(21)169, (01)00884838059115(21)23, (01)00884838054202(21)2173, (01)00884838054202(21)1214, (01)00884838054202(21)52, (01)00884838054202(21)66, (01)00884838054202(21)493, (01)00884838054202(21)994, (01)00884838054202(21)373, (01)00884838059115(21)290, (01)00884838054202(21)1213, (01)00884838054226(21)173, (01)00884838054202(21)339, (01)00884838054202(21)234, (01)00884838054189(21)93, (01)00884838054189(21)796, (01)00884838054189(21)1072, (01)00884838054202(21)1836, (01)00884838054202(21)364, (01)00884838054202(21)982, (01)00884838054202(21)634, (01)00884838059115(21)124, (01)00884838054202(21)190, (01)00884838054202(21)818, (01)00884838054202(21)1394, (01)00884838054202(21)1396, (01)00884838054202(21)1646, (01)00884838054202(21)386, (01)00884838054226(21)119, (01)00884838054226(21)126, (01)00884838054202(21)1650, (01)00884838054189(21)543, (01)00884838054202(21)2275, (01)00884838054189(21)1248, (01)00884838054202(21)1058, (01)00884838054189(21)561, (01)00884838059115(21)274, (01)00884838054202(21)1353, (01)00884838054202(21)1466, (01)00884838054196(21)319, (01)00884838054202(21)71, (01)00884838059115(21)340, (01)00884838059115(21)366, (01)00884838054189(21)1129, (01)00884838054202(21)910, (01)00884838054189(21)781, (01)00884838054202(21)751, (01)00884838054202(21)1340, (01)00884838054202(21)1978, (01)00884838054189(21)344, (01)00884838054189(21)374, (01)00884838054189(21)634, (01)00884838054202(21)254, (01)00884838054202(21)326, (01)00884838054202(21)166, (01)00884838054202(21)431, (01)00884838054189(21)151, (01)00884838054189(21)908, (01)00884838054202(21)11, (01)00884838054202(21)318, (01)00884838054202(21)1211, (01)00884838054219(21)88, (01)00884838054196(21)43, (01)00884838054196(21)101, (01)00884838054202(21)543, (01)00884838054202(21)1651, (01)00884838054189(21)130, (01)00884838054196(21)29, (01)00884838054196(21)50, (01)00884838054202(21)131, (01)00884838054202(21)133, (01)00884838054202(21)138, (01)00884838054202(21)547, (01)00884838054202(21)550, (01)00884838054219(21)56, (01)00884838054202(21)1326, (01)00884838054202(21)2710, (01)00884838054189(21)370, (01)00884838054202(21)267, (01)00884838054202(21)759, (01)00884838054189(21)235, (01)00884838054189(21)190, (01)00884838054202(21)292, (01)00884838054202(21)821, (01)00884838054189(21)259, (01)00884838054202(21)1232, (01)00884838054189(21)323, (01)00884838054189(21)324, (01)00884838054189(21)969, (01)00884838054202(21)925, (01)00884838054189(21)98, (01)00884838054189(21)99, (01)00884838054189(21)100, (01)00884838054202(21)127, (01)00884838054202(21)132, (01)00884838054202(21)141, (01)00884838054202(21)145, (01)00884838054202(21)180, (01)00884838054202(21)160, (01)00884838054202(21)468, (01)00884838054202(21)961, (01)00884838054189(21)142, (01)00884838054202(21)1736, (01)00884838059115(21)162, (01)00884838054202(21)1619, (01)00884838054189(21)1246, (01)00884838054202(21)2933, (01)00884838054189(21)601, (01)00884838054196(21)112, (01)00884838054202(21)1567, (01)00884838054202(21)289, (01)00884838054202(21)282, (01)00884838054202(21)1130, (01)00884838059115(21)186, (01)00884838054202(21)1100, (01)00884838054202(21)1570, (01)00884838054202(21)529, (01)00884838054202(21)1385, (01)00884838059115(21)4, (01)00884838054189(21)877, (01)00884838054196(21)240, (01)00884838054196(21)241, (01)00884838054202(21)1267, (01)00884838059115(21)196, (01)00884838059115(21)405, (01)00884838054202(21)464, (01)00884838054202(21)2103, (01)00884838054202(21)1395, (01)00884838054202(21)1408, (01)00884838054202(21)280, (01)00884838054202(21)741, (01)00884838054202(21)211, (01)00884838054202(21)261, (01)00884838054202(21)1269, (01)00884838054202(21)1837, (01)00884838054219(21)95, (01)00884838059115(21)156, (01)00884838054202(21)601, (01)00884838054202(21)854, (01)00884838054202(21)1051, (01)00884838054202(21)1988, (01)00884838054226(21)60, (01)00884838059115(21)146, (01)00884838054202(21)744, (01)00884838054202(21)956, (01)00884838054189(21)204, (01)00884838054202(21)2020, (01)00884838054219(21)126, (01)00884838054202(21)2601, (01)00884838054202(21)1261, (01)00884838054202(21)1835, (01)00884838054202(21)559, (01)00884838054202(21)967, (01)00884838054189(21)843, (01)00884838054189(21)1038, (01)00884838054189(21)1231, (01)00884838054196(21)175, (01)00884838054196(21)298, (01)00884838054189(21)114, (01)00884838054202(21)1483, (01)00884838054219(21)94, (01)00884838054202(21)2846, (01)00884838059115(21)285, (01)00884838054202(21)526, (01)00884838054202(21)2745, (01)00884838054189(21)1287, (01)00884838054202(21)2249, (01)00884838054189(21)878, (01)00884838054202(21)1103, (01)00884838054202(21)1311, (01)00884838054202(21)880, (01)00884838054202(21)946, (01)00884838054202(21)949, (01)00884838054189(21)465, (01)00884838054202(21)518, (01)00884838054202(21)519, (01)00884838054202(21)2645, (01)00884838054202(21)731, (01)00884838054202(21)678, (01)00884838054202(21)1116, (01)00884838054202(21)1880, (01)00884838054202(21)911, (01)00884838054202(21)118, (01)00884838054202(21)1705, (01)00884838054202(21)2192, (01)00884838054202(21)142, (01)00884838054226(21)37, (01)00884838054226(21)38, (01)00884838054202(21)376, (01)00884838054189(21)558, (01)00884838054202(21)67, (01)00884838059115(21)277, (01)00884838054202(21)273, (01)00884838054202(21)1171, (01)00884838054202(21)1498, (01)00884838054202(21)1156, (01)00884838054202(21)1279, (01)00884838054189(21)391, (01)00884838054189(21)389, (01)00884838054202(21)522, (01)00884838054226(21)99, (01)00884838054202(21)564, (01)00884838059115(21)65, (01)00884838054189(21)633, (01)00884838054202(21)158, (01)00884838054202(21)1708, (01)00884838054202(21)1710, (01)00884838054202(21)558, (01)00884838054202(21)521, (01)00884838054202(21)664, (01)00884838054226(21)130, (01)00884838054202(21)906, (01)00884838054202(21)1155, (01)00884838054202(21)1085, (01)00884838054202(21)811, (01)00884838054196(21)280, (01)00884838054202(21)462, (01)00884838054202(21)677, (01)00884838054202(21)316, (01)00884838054202(21)1946, (01)00884838054202(21)184, (01)00884838054202(21)185, (01)00884838054226(21)48, (01)00884838054189(21)1050, (01)00884838054202(21)1834, (01)00884838054202(21)675, (01)00884838054226(21)41, (01)00884838054226(21)157, (01)00884838054271(21)3, (01)00884838054202(21)1652, (01)00884838054189(21)909, (01)00884838054189(21)1000, (01)00884838054189(21)600, (01)00884838054202(21)1011, (01)00884838054202(21)203, (01)00884838054202(21)204, (01)00884838059115(21)168, (01)00884838054202(21)1508, (01)00884838054189(21)841, (01)00884838054196(21)107, (01)00884838054202(21)346, (01)00884838054202(21)2615, (01)00884838054202(21)1890, (01)00884838054202(21)2293, (01)00884838054202(21)618, (01)00884838054189(21)185, (01)00884838054202(21)262, (01)00884838054202(21)580, (01)00884838054196(21)183, (01)00884838054196(21)222, (01)00884838054202(21)654, (01)00884838059115(21)56, (01)00884838054202(21)1149, (01)00884838054202(21)1484, (01)00884838054202(21)1995, (01)00884838054202(21)1397, (01)00884838054202(21)1456, (01)00884838054189(21)394, (01)00884838054189(21)713, (01)00884838059115(21)178, (01)00884838054219(21)30, (01)00884838054189(21)731, (01)00884838054202(21)274, (01)00884838054202(21)1288, (01)00884838054202(21)2906, (01)00884838054196(21)41, (01)00884838054202(21)402, (01)00884838054202(21)1556, (01)00884838054202(21)1201, (01)00884838054202(21)1129, (01)00884838054226(21)141, (01)00884838054202(21)976, (01)00884838054189(21)522, (01)00884838059115(21)138, (01)00884838054202(21)479, (01)00884838054202(21)2348, (01)00884838054202(21)2641, (01)00884838054189(21)75, (01)00884838054202(21)447, (01)00884838054202(21)805, (01)00884838054202(21)922, (01)00884838054189(21)646, (01)00884838054196(21)202, (01)00884838054202(21)973, (01)00884838054202(21)1068, (01)00884838054202(21)1069, (01)00884838054226(21)137, (01)00884838054202(21)371, (01)00884838054202(21)23040202, (01)00884838054202(21)167, (01)00884838054189(21)728, (01)00884838054202(21)485, (01)00884838054219(21)31, (01)00884838054202(21)1095, (01)00884838054202(21)1870, (01)00884838054202(21)2253, (01)00884838054189(21)223, (01)00884838054202(21)892, (01)00884838059115(21)212, (01)00884838054202(21)130, (01)00884838054202(21)2295, (01)00884838054202(21)2071, (01)00884838054202(21)1327, (01)00884838054202(21)903, (01)00884838054202(21)1099, (01)00884838059115(21)135, (01)00884838054189(21)765, (01)00884838054226(21)49, (01)00884838054196(21)164, (01)00884838054196(21)153, (01)00884838054202(21)1407, (01)00884838054202(21)620, (01)00884838054202(21)176, (01)00884838054202(21)257, (01)00884838054202(21)1920, (01)00884838054202(21)205, (01)00884838054202(21)2707, (01)00884838054202(21)2709, (01)00884838054202(21)2174, (01)00884838054202(21)819, (01)00884838054202(21)151, (01)00884838054202(21)539, (01)00884838054202(21)1275, (01)00884838059115(21)257, (01)00884838054202(21)656, (01)00884838054202(21)361, (01)00884838054202(21)721, (01)00884838054202(21)1142, (01)00884838054219(21)21, (01)00884838054189(21)192, (01)00884838054202(21)779, (01)00884838054202(21)1111, (01)00884838054202(21)463, (01)00884838054202(21)1122, (01)00884838054189(21)959, (01)00884838054202(21)481, (01)00884838054202(21)806, (01)00884838054219(21)97, (01)00884838054202(21)310, (01)00884838054202(21)491, (01)00884838054202(21)2151, (01)00884838059115(21)337, (01)00884838054189(21)825, (01)00884838054196(21)335, (01)00884838054189(21)942, (01)00884838054202(21)1352, (01)00884838054189(21)1192, (01)00884838054202(21)888, (01)00884838054202(21)697, (01)00884838054202(21)1755, (01)00884838054189(21)990, (01)00884838054202(21)1855, (01)00884838054202(21)445, (01)00884838054202(21)80, (01)00884838054189(21)381, (01)00884838054202(21)840, (01)00884838054202(21)842, (01)00884838054202(21)2310, (01)00884838054202(21)2506, (01)00884838054226(21)63, (01)00884838054202(21)655, (01)00884838054202(21)691, (01)00884838054202(21)379, (01)00884838054189(21)774, (01)00884838054202(21)553, (01)00884838054202(21)377, (01)00884838054202(21)632, (01)00884838054226(21)35, (01)00884838054202(21)638, (01)00884838059115(21)265, (01)00884838054202(21)2007, (01)00884838054202(21)2008, (01)00884838054202(21)968, (01)00884838054202(21)781, (01)00884838054189(21)368, (01)00884838054202(21)154, (01)00884838054202(21)774, (01)00884838054189(21)245, (01)00884838054202(21)1850, (01)00884838054202(21)1522, (01)00884838054196(21)288, (01)00884838054189(21)484, (01)00884838054189(21)485, (01)00884838054189(21)648, (01)00884838054196(21)342, (01)00884838059115(21)109, (01)00884838054189(21)966, (01)00884838054189(21)1268, (01)00884838054202(21)451, (01)00884838054196(21)134, (01)00884838054196(21)156, (01)00884838054189(21)109, (01)00884838054189(21)110, (01)00884838054196(21)265, (01)00884838054196(21)306, (01)00884838054196(21)307, (01)00884838054202(21)140, (01)00884838054202(21)1413, (01)00884838054202(21)1448, (01)00884838054202(21)1538, (01)00884838054189(21)116, (01)00884838054189(21)604, (01)00884838054189(21)627, (01)00884838059115(21)134, (01)00884838054189(21)319, (01)00884838054196(21)152, (01)00884838054196(21)106, (01)00884838054196(21)169, (01)00884838059115(21)71, (01)00884838054202(21)1930, (01)00884838059115(21)238, (01)00884838054202(21)743, (01)00884838054202(21)340, (01)00884838054202(21)535, (01)00884838054202(21)938, (01)00884838054202(21)31, (01)00884838054202(21)206, (01)00884838059115(21)190, (01)00884838054189(21)112, (01)00884838054196(21)42, (01)00884838054202(21)251, (01)00884838054219(21)22, (01)00884838054189(21)716, (01)00884838054196(21)203, (01)00884838054219(21)91, (01)00884838054189(21)396, (01)00884838054226(21)167, (01)00884838054202(21)990, (01)00884838054202(21)1081, (01)00884838054202(21)808, (01)00884838054202(21)1633, (01)00884838054202(21)1634, (01)00884838059115(21)219, (01)00884838054202(21)315, (01)00884838054226(21)71, (01)00884838054202(21)1387, (01)00884838054202(21)1630, (01)00884838054202(21)143, (01)00884838054189(21)531, (01)00884838054196(21)234, (01)00884838054202(21)586, (01)00884838054189(21)1182, (01)00884838054202(21)989, (01)00884838054202(21)1824, (01)00884838054189(21)156, (01)00884838054189(21)253, (01)00884838054202(21)236, (01)00884838054202(21)237, (01)00884838054202(21)238, (01)00884838054202(21)356, (01)00884838054202(21)1481, (01)00884838054226(21)96, (01)00884838054202(21)717, (01)00884838054189(21)965, (01)00884838054226(21)55, (01)00884838054202(21)887, (01)00884838054189(21)444, (01)00884838054189(21)1189, (01)00884838054202(21)1202, (01)00884838054202(21)541, (01)00884838054202(21)565, (01)00884838054202(21)416, (01)00884838054202(21)336, (01)00884838059115(21)197, (01)00884838054202(21)303, (01)00884838054202(21)476, (01)00884838054202(21)2407, (01)00884838054189(21)220, (01)00884838054189(21)258, (01)00884838054202(21)189, (01)00884838054202(21)2635, (01)00884838054189(21)1126, (01)00884838054202(21)1809, (01)00884838054202(21)538, (01)00884838054202(21)904, (01)00884838054189(21)1210, (01)00884838054202(21)785, (01)00884838054189(21)1239, (01)00884838054189(21)102, (01)00884838054189(21)1215, (01)00884838054202(21)2083, (01)00884838054202(21)350, (01)00884838054202(21)473, (01)00884838054189(21)696, (01)00884838054202(21)329, (01)00884838054202(21)549, (01)00884838054202(21)874, (01)00884838054189(21)11, (01)00884838054189(21)297, (01)00884838054189(21)560, (01)00884838054189(21)562, (01)00884838054202(21)669, (01)00884838054202(21)1049, (01)00884838054202(21)684, (01)00884838054202(21)1333, (01)00884838054202(21)582, (01)00884838054202(21)224, (01)00884838059115(21)325, (01)00884838054202(21)1264, (01)00884838054202(21)281, (01)00884838054202(21)475, (01)00884838054202(21)981, (01)00884838054202(21)1447, (01)00884838054189(21)832, (01)00884838054202(21)696, (01)00884838054202(21)1188, (01)00884838054202(21)1189, (01)00884838054202(21)966, (01)00884838054189(21)335, (01)00884838054189(21)664, (01)00884838054202(21)333, (01)00884838054189(21)845, (01)00884838054202(21)1875, (01)00884838054202(21)128, (01)00884838054189(21)778, (01)00884838054202(21)1405, (01)00884838054202(21)1482, (01)00884838054189(21)215, (01)00884838054202(21)930, (01)00884838054202(21)932, (01)00884838054202(21)498, (01)00884838054202(21)1001, (01)00884838054189(21)935, (01)00884838054202(21)647, (01)00884838054202(21)674, (01)00884838054202(21)864, (01)00884838054202(21)1041, (01)00884838054189(21)782, (01)00884838054202(21)1054, (01)00884838054202(21)698, (01)00884838054202(21)1032, (01)00884838054219(21)110, (01)00884838054196(21)209, (01)00884838054196(21)267, (01)00884838054219(21)63, (01)00884838054219(21)100, (01)00884838054202(21)2252, (01)00884838054189(21)614, (01)00884838054189(21)222, (01)00884838054202(21)260, (01)00884838054202(21)630, (01)00884838054196(21)284, (01)00884838054189(21)205, (01)00884838054202(21)275, (01)00884838054189(21)115, (01)00884838054189(21)284, (01)00884838054202(21)419, (01)00884838054189(21)694, (01)00884838054202(21)917, (01)00884838054202(21)1266, (01)00884838054202(21)1472, (01)00884838054202(21)2070, (01)00884838054219(21)60, (01)00884838054202(21)971, (01)00884838059115(21)24, (01)00884838054202(21)1014, (01)00884838059115(21)123, (01)00884838054196(21)263, (01)00884838054202(21)1200, (01)00884838054202(21)1374, (01)00884838054189(21)74, (01)00884838054202(21)1499, (01)00884838054202(21)1222, (01)00884838054189(21)838, (01)00884838054189(21)244, (01)00884838054202(21)426, (01)00884838054202(21)459, (01)00884838054189(21)973, (01)00884838054202(21)592, (01)00884838054196(21)127, (01)00884838054202(21)1514, (01)00884838054219(21)55, (01)00884838054226(21)70, (01)00884838054202(21)531, (01)00884838054202(21)456, (01)00884838054202(21)571, (01)00884838054189(21)985, (01)00884838054202(21)867, (01)00884838054202(21)891, (01)00884838054202(21)2110, (01)00884838059115(21)319, (01)00884838054189(21)101, (01)00884838054202(21)625, (01)00884838054202(21)452, (01)00884838054202(21)453, (01)00884838059115(21)378, (01)00884838054202(21)672, (01)00884838054202(21)136, (01)00884838054202(21)137, (01)00884838054226(21)39, (01)00884838054189(21)855, (01)00884838054202(21)530, (01)00884838054189(21)287, (01)00884838059115(21)61, (01)00884838054202(21)2200, (01)00884838054189(21)378, (01)00884838054202(21)48, (01)00884838054202(21)1783, (01)00884838054202(21)1350, (01)00884838054202(21)1723, (01)00884838054202(21)1454, (01)00884838054189(21)612, (01)00884838054202(21)2922, (01)00884838059115(21)205, (01)00884838054202(21)324, (01)00884838054189(21)725, (01)00884838054219(21)62, (01)00884838054202(21)1098, (01)00884838054189(21)914, (01)00884838059115(21)149, (01)00884838054202(21)256, (01)00884838059115(21)264, (01)00884838054202(21)983, (01)00884838059115(21)167, (01)00884838054189(21)805, (01)00884838054202(21)1856, (01)00884838059115(21)365, (01)00884838059115(21)199, (01)00884838054202(21)978, (01)00884838054226(21)62, (01)00884838054202(21)1132, (01)00884838054202(21)1187, (01)00884838054202(21)363, (01)00884838054202(21)1889, (01)00884838054202(21)1076, (01)00884838054202(21)952, (01)00884838054189(21)622, (01)00884838054202(21)499, (01)00884838054196(21)116, (01)00884838054196(21)174, (01)00884838059115(21)278, (01)00884838054202(21)1441, (01)00884838054202(21)210, (01)00884838054202(21)720, (01)00884838054202(21)556, (01)00884838054196(21)32, (01)00884838054202(21)2843, (01)00884838054202(21)560, (01)00884838054189(21)234, (01)00884838054196(21)39, (01)00884838054196(21)49, (01)00884838054196(21)56, (01)00884838054202(21)194, (01)00884838054202(21)195, (01)00884838054202(21)197, (01)00884838054202(21)227, (01)00884838054202(21)229, (01)00884838054196(21)120, (01)00884838054219(21)129, (01)00884838054202(21)627, (01)00884838059115(21)215, (01)00884838054202(21)1457, (01)00884838054202(21)139, (01)00884838054202(21)552, (01)00884838054189(21)1293, (01)00884838054202(21)2284, (01)00884838054189(21)121, (01)00884838054202(21)217, (01)00884838054202(21)228, (01)00884838054226(21)46, (01)00884838054196(21)123, (01)00884838054196(21)133, (01)00884838054196(21)305, (01)00884838054202(21)122, (01)00884838054202(21)757, (01)00884838054202(21)1424, (01)00884838054202(21)2647, (01)00884838054196(21)246, (01)00884838054202(21)893, (01)00884838059115(21)288, (01)00884838054202(21)879, (01)00884838054226(21)118, (01)00884838054202(21)924, (01)00884838054202(21)934, (01)00884838054202(21)1854, (01)00884838054202(21)313, (01)00884838054189(21)544, (01)00884838054202(21)1004, (01)00884838054202(21)528, (01)00884838054189(21)79, (01)00884838054189(21)559, (01)00884838054189(21)1205, (01)00884838054202(21)159, (01)00884838054202(21)1373, (01)00884838054202(21)1846, (01)00884838054202(21)962, (01)00884838054202(21)1984, (01)00884838054202(21)2422, (01)00884838054202(21)494, (01)00884838054202(21)1949, (01)00884838059115(21)254, (01)00884838054202(21)918, (01)00884838054202(21)998, (01)00884838054189(21)617, (01)00884838054226(21)67, (01)00884838054202(21)1463, (01)00884838054202(21)1191, (01)00884838054202(21)1212, (01)00884838054202(21)1370, (01)00884838054202(21)1002, (01)00884838054189(21)1101, (01)00884838054202(21)490, (01)00884838054202(21)2834, (01)00884838054189(21)738, (01)00884838054202(21)382, (01)00884838054202(21)2760, (01)00884838054189(21)957, (01)00884838054202(21)1600, (01)00884838054202(21)1244, (01)00884838054202(21)1030, (01)00884838054202(21)207, (01)00884838054202(21)208, (01)00884838054202(21)1869, (01)00884838059115(21)94, (01)00884838054189(21)400, (01)00884838054189(21)431, (01)00884838054202(21)2196, (01)00884838054202(21)1286, (01)00884838059115(21)304, (01)00884838054202(21)636, (01)00884838054202(21)901, (01)00884838054202(21)1446, (01)00884838054202(21)1828, (01)00884838054196(21)255, (01)00884838054202(21)1349, (01)00884838054202(21)1351, (01)00884838054202(21)561, (01)00884838054189(21)602, (01)00884838054202(21)680, (01)00884838054202(21)1074, (01)00884838054202(21)1677, (01)00884838059115(21)279, (01)00884838054202(21)908, (01)00884838054202(21)1629, (01)00884838054189(21)201, (01)00884838054202(21)420, (01)00884838054202(21)1, (01)00884838054202(21)272, (01)00884838054202(21)449, (01)00884838054202(21)516, (01)00884838054202(21)533, (01)00884838054202(21)991, (01)00884838054202(21)422, (01)00884838054226(21)78, (01)00884838059115(21)171, (01)00884838054196(21)40, (01)00884838059115(21)82, (01)00884838059115(21)85, (01)00884838054189(21)1340, (01)00884838054202(21)1034, (01)00884838054202(21)889, (01)00884838054202(21)1822, (01)00884838054202(21)306, (01)00884838054202(21)900, (01)00884838054196(21)178, (01)00884838054202(21)914, (01)00884838054226(21)120, (01)00884838059115(21)202, (01)00884838054202(21)671, (01)00884838059115(21)99, (01)00884838054202(21)882, (01)00884838054202(21)372, (01)00884838054202(21)695, (01)00884838054202(21)945, (01)00884838054202(21)125, (01)00884838054202(21)368, (01)00884838054189(21)122, (01)00884838054202(21)1136, (01)00884838054202(21)1639, (01)00884838054189(21)653, (01)00884838054189(21)663, (01)00884838054202(21)215, (01)00884838054202(21)279, (01)00884838054196(21)104, (01)00884838054202(21)347, (01)00884838054202(21)909, (01)00884838054189(21)688, (01)00884838054202(21)631, (01)00884838054202(21)637, (01)00884838059115(21)182, (01)00884838054189(21)563, (01)00884838054219(21)71, (01)00884838054202(21)161, (01)00884838054202(21)534, (01)00884838054202(21)242, (01)00884838054202(21)284, (01)00884838059115(21)22, (01)00884838054202(21)375, (01)00884838054226(21)7, (01)00884838059115(21)200, (01)00884838054189(21)704, (01)00884838054202(21)365, (01)00884838054202(21)579, (01)00884838054202(21)1820, (01)00884838054202(21)809, (01)00884838054202(21)1331, (01)00884838054202(21)1566, (01)00884838054189(21)462, (01)00884838054202(21)1598, (01)00884838054202(21)407, (01)00884838054202(21)489, (01)00884838054202(21)1826, (01)00884838054189(21)191, (01)00884838054202(21)1368, (01)00884838054189(21)931, (01)00884838054202(21)155, (01)00884838054189(21)967, (01)00884838054202(21)1649, (01)00884838054226(21)106, (01)00884838054202(21)496, (01)00884838054202(21)1549, (01)00884838054202(21)1568, (01)00884838054202(21)1845, (01)00884838054202(21)1980, (01)00884838054202(21)710, (01)00884838054202(21)793, (01)00884838054202(21)213, (01)00884838054202(21)692, (01)00884838054202(21)929, (01)00884838054202(21)861, (01)00884838059115(21)129, (01)00884838054202(21)1035, (01)00884838059115(21)59, (01)00884838054202(21)1024, (01)00884838054202(21)1256, (01)00884838054189(21)265, (01)00884838054202(21)222, (01)00884838054202(21)394, (01)00884838054202(21)428, (01)00884838054202(21)1022, (01)00884838054202(21)343, (01)00884838054202(21)424, (01)00884838054202(21)435, (01)00884838054202(21)437, (01)00884838054219(21)36, (01)00884838054202(21)1811, (01)00884838059115(21)172, (01)00884838054189(21)826, (01)00884838054196(21)266, (01)00884838054202(21)1168, (01)00884838054202(21)940, (01)00884838054202(21)1657.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Vietnam, Yemen.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems Nederl
All 200| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay | |
| Device | CLASS II | Philips Allura, Cardio Vascular-Allura Centron recalled | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Allura Xper with the following recalled | Philips Medical Systems Nederl | Other | |
| Device | CLASS II | Philips MultiDiagnost Eleva with the following recalled | Philips Medical Systems Nederl | Other | |
| Device | CLASS II | Philips Azurion 5M12 recalled by Philips Medical Systems | Philips Medical Systems Nederl | Device Malfunction | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |