RecallHawk
Class I Recall

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Summary

The FDA issued a Class I for Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Possibility of the patient falling from the table related to the mattress used on the patient table..

Details

Source

Device Recall

External ID

Z-1142-2025

Action Date

2025-02-26

Status

Ongoing

Category

device

Product Description

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

Lot/Code Info: Catalog numbers: (1) 722003, (2) 722010, (3) 722026; UDI-DI: (1) No UDI, (2) 00884838059030, (3) 00884838054189; Serial Numbers: (1) 285, 1634, 1349, 1153, 1154, 1472, 803, 1694, 1599, 1460, 1138, 1532, 940, 1214, 1627, 1728, 1189, 1311, 1700, 1187, 1222, 1651, 1353, 939, 1326, 445, 1223, 76986, 1023, 917, 1615, 1732, 1761, 367, 1078, 690, 1529, 1624, 997616, 1663, 1667, 928, 1449, 968, 1286, 72, 1621, 1622, 1643, 472, 1799, 1514, 1525, 1114, 1584, 1647, 1555, 1482, 1489, 1443, 1444, 1072, 1954, 1704, 1232, 1266, 1089, 1259, 1787, 1910, 1714, 1159, 1133, 1135, 1512, 892, 1084, 1031, 1067, 2936, 1411, 1271, 1807, 871, 1805, 1354, 1430, 8198, 1869, 634919, 485, 1594, 467, 1551, 390, 912, 913, 8091, 1471, 1474, 1446, 1092, 1718, 833, 1491, 1738, 1749, 1637, 1255, 1462, 1132, 1463, 1633, 1374, 1675, 691, 292, 1751, 1802, 1593, 1105, 1107, 1108, 1702, 1277, 1684, 1568, 1569, 1570, 1743, 1109, 1620, 1726, 639, 797, 1377, 1065, 4.5161E+15, 1708, 1709, 1328, 1592, 1121, 1295, 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862, 804, 96, 396, 254, 330, 367, 473, 515, 909, 220, 1439, 373, 875, 112, 1152, 563, 900, 312, 313, 121, 1074, 1075, 807, 564, 1193, 762, 357, 1092, 1066, 834, 184, 857, 697, 634, 980, 1185, 1055, 782, 1096, 125, 225, 812, 813, 368, 913, 349, 354, 781, 235, 236, 549, 570, 388, 387, 386, 525, 251, 278, 868, 774, 1006, 1060, 516, 517, 403, 1030, 1031, 597, 492, 908, 845, 846, 507, 923, 687, 607, 817, 381, 60, 775, 78, 166, 501, 719, 185, 130, 1147, 141, 599, 689 ****Serial Numbers Added 5/2/2025**** 28, 60, 70, 75, 78, 112, 132, 246, 268, 289, 396; (3) 156, 253, 287, 825, 394, 713, 74, 462, 192, 191, 204, 155, 1132, 967, 205, 1246, 122, 259, 185, 618, 531, 855, 235, 805, 725, 832, 368, 646, 653, 663, 965, 602, 908, 959, 1129, 664, 778, 109, 110, 116, 117, 115, 284, 389, 841, 223, 694, 222, 374, 634, 622, 436, 878, 1192, 102, 914, 396, 704, 370, 782, 1210, 201, 774, 696, 838, 344, 563, 731, 233, 1126, 543, 93, 796, 1072, 601, 245, 234, 1340, 604, 627, 190, 605, 935, 11, 297, 560, 562, 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199, 132, 816, 274, 1184, 1105, 1169, 867, 869, 772, 714, 1120, 968, 810, 157, 311, 480, 610, 363, 1045, 896, 652, 508, 217, 662, 1102, 950, 1027, 937, 702, 1196, 516, 583, 580, 125, 498, 88, 361, 1163, 471, 661, 951, 275, 303, 590, 1371, 1150, 1281, 1062, 741, 1275, 898, 353, 1090, 249, 227, 1216, 1096, 1191, 1098, 476, 496, 139, 148, 214, 987, 421, 836, 1359, 1006, 740, 666, 943, 489, 625, 491, 1243, 487, 1240, 932, 649, 1185, 1190, 1044, 739, 1194, 761, 1241, 1242, 624, 393, 1021, 1097, 1070, 228, 269, 270, 372, 375, 425, 426, 427, 428, 449, 450, 472, 503, 687, 751, 753, 884, 902, 1026, 1029, 1113, 1123, 1199, 1305, 1329, 1355, 1356, 1360, 1361, 1362, 1363, 1364, 1366, 40, 1108, 1264, 1265, 14, 25, 570, 126, 164, 542, 566, 978, 1201, 1202, 127, 532, 889, 547, 706, 1365, 417, 206, 1206, 1207, 466, 442, 443, 105, 1357, 38, 870, 486, 70, 974, 106, 655, 669, 83, 160, 260, 211, 907, 198, 495, 1251, 793, 469, 268, 876, 568, 958, 1033, 1158, 975, 803, 184, 461, 895, 936, 1030, 1064, 1347, 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502, 620, 675, 302, 1175, 719, 915, 1225, 1117, 1233, 1322 ****Serial Numbers Added 5/2/2025**** 86, 195, 196.

Quantity Affected: 2,274 units (459 US, 1815 OUS)

Reason for Recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Distribution

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, 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 Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, 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, Venezuela, Viet Nam, Yemen.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-01-13

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 167 device recalls issued in the same week, part of 413 device-related FDA actions this month.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1142-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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