Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier
FDA device recall Z-0367-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Action taken
- On 12/14/05 and 12/20/06 the firm issued a letter dated 12/12/06 to their customers. The letter explains the problem and states that the firm will be performing mandatory upgrades to correct the situation. Consignees will be contacted to arrange for service.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 140 devices total
- Distribution
- Units were distributed to hospitals and medical centers nationwide.
- Date initiated
- 2006-12-14
- Date posted
- 2007-01-25
- Date terminated
- 2011-10-14
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS (K984545) | Philips Medical Systems North America, Inc. | 1999-02-25 |