Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20-
FDA device recall Z-2976-2011 · posted 2011-08-10 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period.
- Action taken
- Philips Health Care North America sent a FIELD SAFETY CORRECTION ACTION letter dated July 4, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. This FCD will be identified as FCD72200200 and will be free of charge. This FCD consists a CD with the correct firmware and a installation procedure to implement the FCD correctly. Please contact your local Philips representative. For further follow up please call (978 ) 687-1501.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 1423 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-07-08
- Date posted
- 2011-08-10
- Date terminated
- 2014-05-14
- 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 |
| ALLURA XPER FD20 (K033737) | Philips Medical Systems North America, Inc. | 2003-12-09 |
| PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 (K031333) | Philips Medical Systems North America, Inc. | 2003-05-13 |