Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnost
FDA device recall Z-0924-2017 · posted 2017-01-20 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
- Action taken
- Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 2
- Distribution
- US: WA OUS: China, Spain, Korea, Republic of, Germany
- Date initiated
- 2016-12-01
- Date posted
- 2017-01-20
- Date terminated
- 2017-08-10
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD; OR TABLE (K133292) | Philips Medical Systems Nederland B.V. | 2014-03-05 |