Recalls / —

—#48182

Product

Allura Xper FD 10 x-ray, angiographic system

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K041949

Affected lot / code info

Site codes listed in Z-0161-2007 for FD 10/10.

Why it was recalled

Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.

Root cause (FDA determination)

Other

Action the firm took

A letter dated September 1, 2006 was sent to customers on September 5, 2006. The letter advised customers of the problem and advised a service representative will visit the consignee to install a new software upgrade.

Recalling firm

Firm

Philips Medical Systems North America Co. Phillips

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2006-08-24

Posted by FDA

2006-11-08

Terminated

2008-05-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #48182. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.