Recall Z-2716-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
| Date | Aug 22, 2024 (initiated Aug 8, 2024) |
| Status | Open, Classified |
| Reason | A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction notification letter dated 7/31/24 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients. a. Affected systems may continue to be used in accordance with the Instructions for Use (IFU). b. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a place likely to be seen/viewed. c. Circulate this notice to all users of the system so that they are aware of the issue. d. Should you experience uncontrolled C-arm m |
| Quantity | 6 units |
| Distribution | Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK. |
| 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 |