GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System
This recall has been terminated (originally issued September 24, 2009).
- 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
- Official Source
- View on FDA website ↗
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.