Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, i
FDA device recall Z-0923-2017 · 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
- IZI
- Quantity affected
- 1
- 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD10 (K041949) | Philips Medical Systems North America Co. | 2004-07-30 |