Recall Z-2208-2012 ยท IXR Table, Radiographic, Tilting
Philips Healthcare Inc.
Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
| Date | Aug 15, 2012 (initiated Jul 11, 2012) |
| Status | Terminated |
| Reason | Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors. |
| Root cause | Equipment maintenance |
| Action | Philips issued an Urgent Field Safety Notice dated July 9, 2012, to notify users that the inclination swtich may be mounted incorrectly. A Field Safety Engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly they will re-install it properly. The Field Service Engineer will add a label as described in the spare part replacement manual, which is part of the FCO kit.. Customers were instructed review the information contained in the Field Safety Notice and to retain a copy of the notice with the equipment Instruction for Use. For |
| Quantity | 12 units |
| Distribution | Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand. |
| FDA record | Open on fda.gov |