GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System

Date posted by the FDA

Sept. 24, 2009

Status

Terminated

Filed by

Ge Healthcare

Product

GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System

Reason

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.

Distribution pattern

Worldwide Distribution

Quantity

554 units

Codes and lots

n/a

Recall started

Feb. 19, 2009

Device type

System, X-Ray, Fluoroscopic, Image-Intensified

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

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.

Recall number

Z-1155-2009

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1155-2009. The agency record governs; check it and the company before acting.