Recall Z-0676-2025 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table,
| Date | Dec 12, 2024 (initiated Nov 11, 2024) |
| Status | Open, Classified |
| Reason | Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and po |
| Root cause | Equipment maintenance |
| Action | Philips Medical Systems notified consignees on 11/11/2024 via letter. Consignees were instructed that affected systems may continue to be used in accordance with their Indications for Use and Instructions for Use (IFU), to keep the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system, circulate this notice to all users of the system so that they are aware of the issue, and if you experience erratic movement of the C-arm and/or if you see a portion of black area on the X-ray image, please call your local Philips representative to report |
| Quantity | 2,782 units |
| Distribution | Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, Franc |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161563 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Jul 29, 2016 |