Allura Xper FD 20/10 x-ray, and fluoroscopy
FDA device recall Z-0166-2007 · posted 2006-11-14 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
- Action taken
- On 10/12/06 the firm issued a letter to their consignees advising of the problem and how to avoid the problem by using specific image formats. If the system should lock up, consignees are to switch the system off and then restart. The firm will be conducting software upgrades to the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and issued a letter on 12/11/06 to affected customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 19 devices
- Distribution
- Nationwide.
- Date initiated
- 2006-10-12
- Date posted
- 2006-11-14
- Date terminated
- 2010-09-24
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD20 (K033737) | Philips Medical Systems North America, Inc. | 2003-12-09 |