Recall Z-2464-2010 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems North America Co. Phillips
Philips BV Endura Mobile X-Ray system with the extended rotation option.
| Date | Sep 22, 2010 (initiated Sep 10, 2008) |
| Status | Terminated |
| Reason | The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement may cause the C-arm to collide with a patient. The brakes function properly if the C-arm is rotated to its maximum positions. |
| Root cause | Other |
| Action | Philips Medical Systems issued an Urgent Product Correction letter dated September 30, 2008 to consignees. The letter identified the affected device, what the problem is and under what circumstances it can occur, and the actions that should be taken by the customer or user in order to prevent risks for patients or users. Philips will contacdt customers to implement Field Corrective Action (FCO) #71800026), which describes a mechanical brake modification which will be installed by Philips. Until the Field Corrective Action has been completed, users should ensure that the C-arm is placed in the |
| Quantity | 71 units |
| Distribution | Nationwide Distribution: Throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010435 | PHILIPS BV PULSERA/ENDURA Philips Medical Systems, Inc., Mar 12, 2001 |