PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper Fluoroscopic X-ray Systems Recalled for Imaging Failure Risk

Agency Publication Date: February 16, 2024

Summary

Philips Medical Systems is recalling approximately 5,500 Allura Xper Interventional Fluoroscopic X-ray Systems because the Dual In-Line Memory Modules (DIMMs) may not perform correctly. This defect can cause the entire system to stop functioning, making medical imaging impossible during a procedure. The recall affects several models including the FD10, FD10/10, FD20, and FD20 Biplane, which are used globally in medical facilities. Philips is initiating this voluntary recall via notification letters to ensure systems are repaired or inspected to prevent procedural delays.

Risk

The memory modules within the system's computer can fail, causing the X-ray system to crash or stop working entirely. This poses a significant risk of delaying critical medical procedures where real-time imaging is necessary for patient safety.

What You Should Do

Identify if your medical facility uses Philips Allura Xper systems, specifically models FD10, FD10/10, FD10C, FD20, FD20 Biplane, FD20 OR Table, FD20/10, FD20/15, or FD20/20.
Check your system's model and serial number against the extensive list of affected units, which includes model numbers 722003, 722010, 722026, 722005, 722011, 722027, 722001, 722006, 722012, 722028, 722008, 722013, 722025, 722023, 722035, 722029, 722058, 722038, and 722039.
Verify the Unique Device Identifier (UDI) on your equipment; affected codes include 00884838059030, 00884838059191, 00884838054189, 00884838054196, 00884838059115, 00884838059054, 00884838059207, 00884838054202, 00884838059269, 00884838059061, 00884838080805, 00884838059085, 00884838054240, 00884838054219, and 00884838054226.
Contact your healthcare provider or Philips Medical Systems Nederland B.V. immediately for technical support and instructions on how to receive a system inspection or memory module replacement.
Contact the FDA for additional questions or to report incidents at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

System inspection and potential repair/replacement of memory modules

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Philips Allura Xper FD10

Model / REF:

722003

722010

722026

Lot Numbers:

Serial Numbers: 105, 1181, 1209, 1349, 1435, 1472, 1529, 1555, 1594, 1700, 1719, 1788, 285, 472, 482, 912, 913, 928

UDI-DI 00884838059030/00884838059191 Serials: 1005, 1009, 1011, 1025, 1028, 1040, 1041, 1042, 1043, 1048, 1064, 1069, 107, 1078, 1082, 1084, 1108, 1109, 1112, 1118, 1123, 1126, 1128, 1132, 1144, 1149, 1170, 1173, 1176, 1181, 1183, 1209, 1210, 1214, 1226, 1230, 1233, 1234, 1235, 1236, 1244, 1261, 1263, 1275, 1279, 1283, 1287, 1292, 1297, 1298, 1302, 1308, 1309, 1310, 1312, 1328, 133, 1336, 1344, 1347, 1369, 1370, 1373, 1391, 1395, 1396, 1397, 1398, 1424, 1436, 1440, 1442, 145, 170, 177, 191, 209, 214, 252, 314, 33, 337, 343, 344, 39, 414, 43, 467, 468, 477, 480, 500, 527, 572, 585, 604, 609, 61, 611, 624, 646, 65, 651, 656, 662, 667, 668, 670, 679, 68, 714, 728, 754, 755, 763, 767, 791, 794, 809, 818, 830, 838, 839, 873, 882, 896, 902, 905, 914, 917, 920, 921, 931, 932, 937, 939, 946, 965, 968, 970, 976, 979, 986, 987, 992, 999

UDI-DI 00884838054189 Serials: 100, 101, 102, 1050, 1052, 1068, 109, 11, 110, 112, 114, 115, 116, 117, 1205, 121, 1210, 122, 130, 142, 151, 155, 156, 185, 190, 191, 192, 204, 215, 220, 221, 223, 233, 234, 244, 245, 253, 258, 259, 265, 284, 297, 319, 323, 324, 335, 344, 368, 370, 374, 378, 381, 391, 394, 396, 400, 431, 432, 436, 444, 458, 462, 465, 484, 485, 512, 522, 531, 543, 544, 558, 559, 560, 561, 562, 563, 600, 601, 602, 604, 605, 612, 614, 617, 618, 622, 627, 633, 634, 646, 648, 653, 663, 664, 683, 713, 716, 725, 73, 731, 738, 74, 75, 765, 774, 78, 781, 786, 79, 796, 805, 826, 832, 841, 845, 87, 877, 878, 908, 93, 931, 959, 965, 966, 967, 98, 985, 99

Product: Philips Allura Xper FD10/10

Model / REF:

722005

722011

722027

Lot Numbers:

722005 Serials: 261, 329, 344, 456, 49, 523, 63

722011 Serials: 101, 102, 103, 107, 123, 124, 132, 133, 140, 15, 157, 163, 168, 169, 170, 171, 172, 173, 23, 234, 237, 255, 267, 268, 269, 270, 275, 279, 308, 319, 324, 325, 33, 332, 344, 345, 358, 362, 375, 380, 57, 58, 59, 76, 82, 83, 84, 87

UDI-DI 00884838054196/00884838059191 Serials: 1, 106, 107, 112, 116, 120, 123, 127, 133, 134, 152, 153, 156, 164, 169, 174, 175, 178, 179, 183, 202, 203, 209, 216, 222, 230, 240, 241, 246, 255, 263, 265, 266, 284, 29, 305, 306, 319, 32, 332, 342, 39, 40, 41, 42, 43, 49, 50, 56, 71

Product: Philips Allura Xper FD10C

Model / REF:

722001

Lot Numbers:

Serial Numbers: 213, 273

Product: Philips Allura Xper FD20

Model / REF:

722006

722012

722028

Lot Numbers:

722006 Serials: 1007, 1132, 1210, 1221, 1276, 1420, 1439, 1444, 1446, 1461, 1469, 1476, 1507, 1588, 1589, 1659, 1661, 1705, 1720, 1812, 1830, 1848, 1870, 1875, 1913, 1922, 1942, 1955, 2008, 2126, 2147, 2199, 2203, 2323, 2404, 2425, 45, 468, 518, 559, 638, 673, 675, 683, 722, 723, 774, 804, 806, 810, 886, 904

UDI-DI 00884838059054/059191/059207 Serials: Wide range from 100 to D902-214-00

UDI-DI 00884838054202/059191/059269 Serials: Wide range from 1 to 998

Product: Philips Allura Xper FD20 Biplane

Model / REF:

722008

722013

Lot Numbers:

722008 Serials: 19, 197, 231, 246, 264, 288, 306, 312, 319, 378, 419, 420, 453, 465, 487, 516, 521

UDI-DI 00884838059061/00884838080805 Serials: Wide range from 100 to 96

Product: Philips Allura Xper FD20 Biplane OR Table

Model / REF:

722025

Lot Numbers:

Serial Numbers: 2, 3

Product: Philips Allura Xper FD20 OR Table

Model / REF:

722023

722035

Lot Numbers:

722023 UDI-DI 00884838059085 Serials: 109, 110, 113, 116, 117, 118, 124, 127, 128, 138, 142, 147, 160, 175, 179, 18, 35, 41, 46, 66, 71, 72, 75, 82, 98

722035 UDI-DI 00884838054240 Serials: 100 to 89

Product: Philips Allura Xper FD20/10

Model / REF:

722029

Lot Numbers:

UDI-DI 00884838054219 Serials: 110, 129, 21, 22, 30, 31, 55, 56, 57, 60, 62, 63, 7, 71, 84, 88, 94, 97

Product: Philips Allura Xper FD20/15

Model / REF:

722058

Lot Numbers:

UDI-DI 00884838059115/00884838059191 Serials: 100 to 99

Product: Philips Allura Xper FD20/20

Model / REF:

722038

Lot Numbers:

UDI-DI 00884838054226 Serials: 106 to 96

Product: Philips Allura Xper FD20/20 OR Table

Model / REF:

722039

Lot Numbers:

Serial Number: 3

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93777

Status: Active

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold By: Direct medical distribution; Authorized medical equipment dealers

Manufactured In: Netherlands

Units Affected: 5,500 (1,681 US; 3,819 ROW)

Distributed To: Alabama, Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your medical facility uses Philips Allura Xper systems, specifically models FD10, FD10/10, FD10C, FD20, FD20 Biplane, FD20 OR Table, FD20/10, FD20/15, or FD20/20.

Check your system's model and serial number against the extensive list of affected units, which includes model numbers 722003, 722010, 722026, 722005, 722011, 722027, 722001, 722006, 722012, 722028, 722008, 722013, 722025, 722023, 722035, 722029, 722058, 722038, and 722039.

Verify the Unique Device Identifier (UDI) on your equipment; affected codes include 00884838059030, 00884838059191, 00884838054189, 00884838054196, 00884838059115, 00884838059054, 00884838059207, 00884838054202, 00884838059269, 00884838059061, 00884838080805, 00884838059085, 00884838054240, 00884838054219, and 00884838054226.

Contact your healthcare provider or Philips Medical Systems Nederland B.V. immediately for technical support and instructions on how to receive a system inspection or memory module replacement.

Contact the FDA for additional questions or to report incidents at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Philips Allura Xper FD10

Model / REF:

722003

722010

722026

Lot Numbers:

Serial Numbers: 105, 1181, 1209, 1349, 1435, 1472, 1529, 1555, 1594, 1700, 1719, 1788, 285, 472, 482, 912, 913, 928

Product: Philips Allura Xper FD10/10

Model / REF:

722005

722011

722027

Lot Numbers:

722005 Serials: 261, 329, 344, 456, 49, 523, 63

Product: Philips Allura Xper FD10C

Model / REF:

722001

Lot Numbers:

Serial Numbers: 213, 273

Product: Philips Allura Xper FD20

Model / REF:

722006

722012

722028

Lot Numbers:

UDI-DI 00884838059054/059191/059207 Serials: Wide range from 100 to D902-214-00

UDI-DI 00884838054202/059191/059269 Serials: Wide range from 1 to 998

Product: Philips Allura Xper FD20 Biplane

Model / REF:

722008

722013

Lot Numbers:

722008 Serials: 19, 197, 231, 246, 264, 288, 306, 312, 319, 378, 419, 420, 453, 465, 487, 516, 521

UDI-DI 00884838059061/00884838080805 Serials: Wide range from 100 to 96

Product: Philips Allura Xper FD20 Biplane OR Table

Model / REF:

722025

Lot Numbers:

Serial Numbers: 2, 3

Product: Philips Allura Xper FD20 OR Table

Model / REF:

722023

722035

Lot Numbers:

722023 UDI-DI 00884838059085 Serials: 109, 110, 113, 116, 117, 118, 124, 127, 128, 138, 142, 147, 160, 175, 179, 18, 35, 41, 46, 66, 71, 72, 75, 82, 98

722035 UDI-DI 00884838054240 Serials: 100 to 89

Product: Philips Allura Xper FD20/10

Model / REF:

722029

Lot Numbers:

UDI-DI 00884838054219 Serials: 110, 129, 21, 22, 30, 31, 55, 56, 57, 60, 62, 63, 7, 71, 84, 88, 94, 97

Product: Philips Allura Xper FD20/15

Model / REF:

722058

Lot Numbers:

UDI-DI 00884838059115/00884838059191 Serials: 100 to 99

Product: Philips Allura Xper FD20/20

Model / REF:

722038

Lot Numbers:

UDI-DI 00884838054226 Serials: 106 to 96

Product: Philips Allura Xper FD20/20 OR Table

Model / REF:

722039

Lot Numbers:

Serial Number: 3

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93777

Status: Active

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold By: Direct medical distribution; Authorized medical equipment dealers

Manufactured In: Netherlands

Units Affected: 5,500 (1,681 US; 3,819 ROW)