Recall Z-1251-2015 ยท KPR System, X-Ray, Stationary
Philips Medical Systems, Inc.
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
| Date | Mar 6, 2015 (initiated Jan 23, 2015) |
| Status | Terminated |
| Reason | Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float. |
| Root cause | Process control |
| Action | Philips Healthcare issued notice to foreign Distributors on 1/23/15 to issue and advise customers to stop using the device until a Philips Engineer checks the device. After the engineer verifies that the tube arm, Wall stand and table were properly assembled, the device may be used again. Philips will subsequently install a new Tube Arm and Wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future. Philips will subsequently provide the method to adjust the T-nuts of table to make sure it was properly assembled. |
| Quantity | 71 units |
| Distribution | Worldwide Distribution. Argentina, Australia, Burkina-Faso, Chile, China, Colombia, Ecuador, France, Germany, Hungary, Indonesia, Iraq (NL), Kuwait, Libya, Macedonia, Malaysia, Mayotte, Poland, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, and Uzbekistan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141381 | DURADIAGNOST Philips Healthcare (Suzhou) Co., Ltd., Jun 12, 2014 |