Allura Xper FD 10/10 x-ray, angiographic system
FDA device recall Z-0161-2007 · posted 2006-11-08 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.
- Action taken
- A letter dated September 1, 2006 was sent to customers on September 5, 2006. The letter advised customers of the problem and advised a service representative will visit the consignee to install a new software upgrade.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 90 total devices - FD 10/10 & FD 10
- Distribution
- Nationwide.
- Date initiated
- 2006-08-24
- Date posted
- 2006-11-08
- Date terminated
- 2008-05-29
- 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 |
|---|---|---|
| ALLURA XPER FD10 (K041949) | Philips Medical Systems North America Co. | 2004-07-30 |