Recall Z-1897-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
| Date | May 24, 2024 (initiated May 16, 2024) |
| Status | Open, Classified |
| Reason | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table. |
| Root cause | Under Investigation by firm |
| Action | On May 14, 2024 URGENT Medical Device Correction letters were sent to consignees. Actions that should be taken by the customer / user to lower risks for patients: " Circulate this Urgent Medical Device Correction letter to all users so that they are aware of the issue. " Philips recommends discontinuing use of the system for procedures that can be safely postponed to another time, or for procedures that can be performed with another system. " Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a plac |
| Quantity | 1 unit (OUS) |
| Distribution | Domestic: OK International: India, Spain, U.A.E. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162859 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Dec 2, 2016 |