Interis Allura BiPlane X-Ray System
FDA device recall Z-0022-06 · posted 2005-08-31 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- 1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick.
- Action taken
- A letter issued on 7/25/05 advising customers of problem. The letter advised that an upgrade will be performed.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 43 units
- Distribution
- Devices were distributed to hospitals/medical centers nationwide.
- Date initiated
- 2005-07-27
- Date posted
- 2005-08-31
- Date terminated
- 2008-05-20
- 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 |
|---|---|---|
| PHILIPS INTEGRIS ALLURA (K002016) | Philips Medical Systems North America, Inc. | 2000-09-06 |