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U.S. Department of Health and Human Services

Class 2 Device Recall Mobile X Ray Series

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 Class 2 Device Recall Mobile X Ray Seriessee related information
Date Initiated by FirmSeptember 20, 2012
Date PostedNovember 16, 2012
Recall Status1 Terminated 3 on December 05, 2013
Recall NumberZ-0197-2013
Recall Event ID 63597
Product Classification Image-intensified fluoroscopic x-ray system mobile - Product Code OXO
ProductGE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
Code Information part number: 5421698
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionGE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue. Field Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard. Further questions please call (262) 513-4122.
Quantity in Commerce364 total units installed in US
DistributionNationwide Distribution
Total Product Life CycleTPLC 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.
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