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U.S. Department of Health and Human Services

Class 2 Device Recall GE Definium 8000

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 Class 2 Recall
GE Definium 8000
see related information
Date Posted September 25, 2008
Recall Status1 Open
Recall Number Z-1882-2008
Recall Event ID 49503
Premarket Notification
510(K) Number
K051967 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product GE Healthcare Definium 8000 Digital Radiographic System.
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Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 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, Martinique (French), Netherlands, Norway, Palestine, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, and Yugoslavia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = GE HEALTHCARE
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