Allura Xper FD10/10 x-ray system
FDA Recall Z-0581-06 · Posted 2006-02-28
Advertisement
Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeIZI
Date Initiated2006-02-06
Date Terminated2008-05-20
Product Quantity55 devices total (Allura Xper FD10/10 & Allura Xper FD10)
Reason for Recall
Potential lock-up of system requiring reboot of system.
Firm Action
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
Distribution Pattern
Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement