Allura Xper FD10 x-ray system
FDA device recall Z-0582-06 · posted 2006-02-28 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential lock-up of system requiring reboot of system.
- Action taken
- On 2/6/06 the firm sent a Product Safety Notification letter to the customers that have devices installed. The letter advises of the problem, and to restart the device if it locks up. The letter also states that the firm will be performing upgrades of the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 55 devices total (Allura Xper FD10/10 & Allura Xper FD10)
- Distribution
- Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA.
- Date initiated
- 2006-02-06
- Date posted
- 2006-02-28
- Date terminated
- 2008-05-20
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD20 (K033737) | Philips Medical Systems North America, Inc. | 2003-12-09 |