GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System
FDA device recall Z-1155-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- Ge Healthcare
- 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.
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 554 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-02-19
- Date posted
- 2009-09-24
- Date terminated
- 2011-07-22
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE OEC FLUOROSTAR (K043076) | Ge Oec Medical Systems, Inc. | 2004-12-22 |