Recall Z-1155-2009 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Ge Healthcare
GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System
| Date | Sep 24, 2009 (initiated Feb 19, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 554 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043076 | GE OEC FLUOROSTAR Ge Oec Medical Systems, Inc., Dec 22, 2004 |