—#81454

Product

GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K043076
Affected lot / code info: n/a

Why it was recalled

The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Healthcare sent a customer notification out to all sites that have potentially affected systems. GEHC Surgery will also install a software correction into the affected systems in order to resolve this issue at no charge to the customer. Until the GEHC OEC Fluorostar 7900 has received the corrective software installed, they are encouraging facilities to exercise caution in monitoring the amount of cumulative fluoroscopy time when the affected system is in use.

Recalling firm

Firm: Ge Healthcare
Address: 384 Wright Brothers Dr, Salt Lake City, Utah 84116-2862

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2009-02-19
Posted by FDA: 2009-09-24
Terminated: 2011-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81454. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.