—#51930

Product

Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations.

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K042368
Affected lot / code info: Serial Numbers P3-449 and P3-443

Why it was recalled

X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.

Root cause (FDA determination)

Other

Action the firm took

The firm sent letters out via certified mail from 04/03/2007 through 04/09/2007 to consignees informing them of the issue. The letter indicates that the firm plans to replace consignee's systems with the Practix Convenio Mobile X-ray System at no charge by the end of May 2007.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide: Distributed to Puerto Rico.

Timeline

Recall initiated: 2007-03-23
Posted by FDA: 2007-09-25
Terminated: 2010-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51930. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.