Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
FDA device recall Z-1251-2015 · posted 2015-03-06 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.
- Action taken
- 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. A Philips Service Engineer will contact affected customers to install the solution.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 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
- Date initiated
- 2015-01-23
- Date posted
- 2015-03-06
- Date terminated
- 2016-06-07
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DURADIAGNOST (K141381) | Philips Healthcare (Suzhou) Co., Ltd. | 2014-06-12 |