Recalls / —

—#44169

Product

Allura Xper FD10 x-ray system

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K033737

Affected lot / code info

site numbers provided with the Allura Xper FD10/10

Why it was recalled

Potential lock-up of system requiring reboot of system.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems North America Co. Phillips

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

Nationwide. Devices were distributed to 42 hospitals/medical centers (35 customers have devices set up) throughout the USA.

Timeline

Recall initiated

2006-02-06

Posted by FDA

2006-02-28

Terminated

2008-05-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #44169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.