Definium 5000 X-ray System, model number 5220493 and 5220393-2
FDA device recall Z-1118-2009 · posted 2009-09-25 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure.
- Action taken
- A notification was sent to all affected customer sites alerting them to this issue, with instructions for safe use of the affected systems.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 85
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-03-24
- Date posted
- 2009-09-25
- Date terminated
- 2012-05-16
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEFINIUM 5000 X-RAY SYSTEM (K063283) | Sedecal., Sa. | 2006-11-17 |