Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System pro...
FDA Device Recall #Z-0724-2022 — Class II — November 24, 2021
Recall Summary
| Recall Number | Z-0724-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 24, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America Llc |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | USA: 63 systems R.O.W.: 127 systems |
Product Description
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039. Allura Xper F010 {C+F). 722003 Allura Xper F010/10 722005 Allura Xper F020 722006 Allura Xper F020/10 and F020/20 722008 Allura Xper F010 722010 Altura Xper F010/10 722011 Allura Xper F020 722012 Allura Xper FD20 biplane 722013 Allura Xper FDlO OR Table 722014 Allura Xper FD20 OR Table 722015 Allura Xper FDl0/10 OR Table 722019 Allura Xper FD20 Biplane OR Table 722020 Allura Xper FD10 OR Table 722022 Allura Xper FD20 OR Table 722023 Allura Xper FD10/10 OR Table 722024 Altura Xper FD20 Biplane OR Table 722025 Allura Xper FD10 722026 Allura Xper FD10/10 722027 Altura Xper FD20/10 biplane 722029 Allura Xper FD10 OR Table 722033 Allura Xper FD10/10 OR Table 722034 Allura Xper FD20/10 OR Table 722036 Allure Xper F020/20 722038 Altura Xper FD20/20 biplane OR Table 722039
Reason for Recall
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Distribution Pattern
US Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark Dominican Republic France Germany Greece India Indonesia Iran Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands Philippines Russian Federation Saudi Arabia South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey United Kingdom Virgin Islands (U.S.)
Lot / Code Information
Allura Xper FD10 722003/722026 (US) S/N: 24 40 71 162 191 266 283 294 319 347 406 485 825 959 965 967 985 990 1246 1353 1444 1944 1949 UDI: (01)00884838054189(21)825 (01)00884838054189(21)967 (01)00884838054189(21)1246 (01)00884838054189(21)965 (01)00884838054189(21)959 (01)00884838054189(21)990 (01)00884838054189(21)985 Allura Xper FD10/10 722005 S/N: 144 US OUS: 37 52 74 79 80 108 279 417 459 Allura Xper FD20 722006 S/N: US 44 72 234 246 263 268 327 333 429 469 471 498 514 535 550 554 588 604 718 754 766 861 1174 1274 1355 1400 1783 1831 1844 1878 1886 1931 2018 UDI: (01)00884838054202(21)893 OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554 Allura Xper FD20 Biplane 722008 S/N: 33, 82, 374 (US) OUS: 39 86 224 249 336 384 388 532 Allura Xper FD10 722010 S/N:OUS 163 340 1422 1429 1434 Allura Xper FD20 722012 S/N: OUS 395 463 927 1013 1518 2652 2854 2918 Allura Xper FD20 OR Table 722015 S/N: 30 (OUS) Allura Xper FD10 722026 S/N OUS: 315 701 748 884 888 943 948 960 971 975 978 984 989 995 Allura Xper FD10/10 722027 S/N: OUS 268 278 Allura Xper FD20/10 722029 S/N:OUS 9 Allura Xper FD10 722026 S/N : US 825 959 965 967 985 990 1246 OUS: 11 40 89 102 112 125 151 244 364 408 431 484 568 580 594 597 602 640 643 704 811 940 971 1262 1312 1402 1405 1424 1465 1481 1658 1691 1794 1796 1815 1852 1859 1879 1891 1948 1959 1974 1985 1988 2141 2311 2521 2554 Allura Xper FD10/10 266 722027 S/N: 266 Allura Xper FD20 722028 S/N: 893 UDI: (01)00884838054202(21)893 Allura Xper FD20/10 722029 S/N: 91, 94 US UDI: (01)00884838054219(21)94 OUS: S/N:6
Other Recalls from Philips North America Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1316-2026 | Class II | IQon Spectral CT; Product Code (REF): 728332; | Jan 7, 2026 |
| Z-1318-2026 | Class II | Spectral CT 7500 on Rails; Product Code (REF):... | Jan 7, 2026 |
| Z-1317-2026 | Class II | Spectral CT; Product Code (REF): 728333; | Jan 7, 2026 |
| Z-1315-2026 | Class II | Brilliance iCT; Product Code (REF): 728306; | Jan 7, 2026 |
| Z-1033-2026 | Class II | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient M... | Dec 12, 2025 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.