Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, in
FDA device recall Z-0125-2011 · posted 2010-10-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for table and stand not to move due to a software error.
- Action taken
- Philips Medical Systems North America Co. sent an URGENT - Device Correction, dated September 15, 2010, to their consignees. The letter identified the product, the problem, and the action to be taken. The consignees were informed that there was a potential geometry software lock up during a Digital Rotational Angiography (DRA) run, the stand and table movement may no longer be possible. The consignees were advised that as geometry software errors happen intermittently, no actions can be performed by the consignees to minimize the risk except for not performing DRA procedures until the firm upgrades the software. For question consignees were to contact the Philips Call Center at 800-722-9377 #5, #4, #1 and reference FCO 72200111 or FCO 72200125.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 26 units
- Distribution
- Devices were distributed to hospitals and medical facilities through out the U.S.
- Date initiated
- 2008-08-21
- Date posted
- 2010-10-22
- Date terminated
- 2010-11-19
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD10 (K041949) | Philips Medical Systems North America Co. | 2004-07-30 |