Recall Z-0239-2019 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems Gmbh, DMC
Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
| Date | Sep 19, 2018 |
| Status | Terminated |
| Reason | Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline |
| Root cause | Software design |
| Action | Philips issued letter dated 9/10/18 to advise users of the problem. Philips will install a system software version upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact account when the Field Action Kit is available to be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 71200177. |
| Quantity | 829 units |
| Distribution | Worldwide distribution - US Nationwide and countries of Canada Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Chile China Colombia Czech Republic Denmark Egypt Finland France French Guiana Germany Guadeloupe Hong Kong Hungary India Indonesia Iran Israel Italy Japan Jordan Korea, Repu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST Philips Medical Systems Dmc GmbH, Jul 25, 2014 |