Recall Z-1503-2014 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems, Inc.
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
| Date | Apr 24, 2014 (initiated Mar 17, 2014) |
| Status | Terminated |
| Reason | The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. |
| Root cause | Process control |
| Action | On March 17, 2014, consignees were notified of the recall via letter. The letter explains what the issue is, actions firms can take to avoid or minimize the occurrence of the issue, and the actions planned by Philips to correct the issue. For further information or support concerning this issue, please contact your local Philips Representative. 1-800-722-9377 |
| Quantity | 985 devices |
| Distribution | Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |