Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
FDA device recall Z-0330-2008 · posted 2007-12-07 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Inaccurate anatomical measurements when using the optional SmartMask feature
- Action taken
- The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 53 units
- Distribution
- Nationwide
- Date initiated
- 2007-09-24
- Date posted
- 2007-12-07
- Date terminated
- 2012-05-03
- 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 FD20 (K033737) | Philips Medical Systems North America, Inc. | 2003-12-09 |