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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 Device Recall GE Definium 8000 see related information
Date Initiated by Firm March 07, 2008
Date Posted September 25, 2008
Recall Status1 Terminated 3 on January 07, 2012
Recall Number Z-1882-2008
Recall Event ID 49503
510(K)Number K051967  
Product Classification Digital Radiographic System - 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 WI 53188-1615
For Additional Information Contact
262-544-3894
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = GE HEALTHCARE
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