RecallDepth

GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System

Company
Ge Healthcare
Recall Initiated
February 19, 2009
Posted
September 24, 2009
Terminated
July 22, 2011
Recall Number
Z-1155-2009
Quantity
554 units
Firm Location
Salt Lake City, UT

Reason for Recall

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

Worldwide Distribution

Root Cause

Radiation Control for Health and Safety Act

Action Taken

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.

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