Recall Z-2928-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
| Date | Aug 10, 2026 (initiated Jun 29, 2026) |
| Status | Open, Classified |
| Reason | Firmware issue potentially leading to loss of geometry movements. |
| Root cause | Software design |
| Action | Philips notified consignees on about 06/29/2026 via certified mailed letter titled URGENT Medical Device Correction. Consignees were provided instructions to properly identify affected systems and table configurations, instructions for restarting the geometry when the issue occurs, to ensure the notification is distributed to all relevant users and retained with device documentation until corrective actions are completed. Consignees were also instructed to post the notification letter near affected devices for ease of reviewing, notify recipients if affected units were transferred, and to comp |
| Quantity | 4,252 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133292 | ALLURA XPER FD; OR TABLE Philips Medical Systems Nederland B.V., Mar 5, 2014 |
| K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, Aug 19, 2014 |
| K161563 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Jul 29, 2016 |
| K162859 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Dec 2, 2016 |