Recall Z-1448-2013 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Healthcare Inc.
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
| Date | Jun 17, 2013 (initiated Jan 16, 2013) |
| Status | Terminated |
| Reason | Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Heathcare issued an Urgent - Field Safety Notice letter dated January 11, 2013 to all affected customers to inform them of the systems afffected by this Field Action. The letter identified what the issue is, under what circumstances it may occur, the actions to take to avoid or minimize the occurrence of the issue and the actions planned by Philips to correct the issue. Customers were inform that if they have multiple BuckyDiagnost systems, they will be contacted by a Field Service Engineer to clarify which systems are affected. The Field Service Engineer (FSE) performs a full IATD ( |
| Quantity | 101 units |
| Distribution | Worldwide Distribution - USA Nationwide and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |