GE Healthcare Definium 8000 Digital Radiographic System.
FDA Recall Z-1882-2008 · Posted 2008-09-25
Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeKPR
Date Initiated2008-03-07
Date Terminated2012-01-07
Product Quantity454 (277 US / 177 OUS)
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
Firm Action
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
Distribution Pattern
Worldwide Distribution: USA, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Martinique (French), Netherlands, Norway, Palestine, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, and Yugoslavia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.