GE Healthcare Definium 8000 Digital Radiographic System.
FDA device recall Z-1882-2008 · posted 2008-09-25 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray Images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs rea
- Action taken
- GE sent a Product Safety Notification dated March 7, 2008 to all customers. The letter described the safety issue, affected product, and stated that a GE Healthcare Field Engineer will schedule a field visit to install software updates.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 454 (277 US / 177 OUS)
- Distribution
- Worldwide Distribution: USA, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Mar
- Date initiated
- 2008-03-07
- Date posted
- 2008-09-25
- Date terminated
- 2012-01-07
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS (K051967) | GE Healthcare | 2005-08-09 |