GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium 5000 System is desi
FDA device recall Z-1133-2008 · posted 2008-09-04 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
- Action taken
- A consignee letter dated 12/12/07 was sent to consignees (Director or Manager of Radiological Imaging, Clinical Administrator). The letter stated that an installed collimator failed compliance testing because of a blaze sizing issue. A GE Field Engineer site visit was also conducted (FMI No. 10814 12/18/07) to implement the correction. Contact GE Healthcare at 1-262-544-3894.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 14 devices (12US & 2 OUS)
- Distribution
- MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.
- Date initiated
- 2007-12-17
- Date posted
- 2008-09-04
- Date terminated
- 2008-09-10
- 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 |