—#84491

Product

OmniDiagnost

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K982993
Affected lot / code info: N/A

Why it was recalled

The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2009-07-06
Posted by FDA: 2009-09-24
Terminated: 2011-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84491. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.