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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Optima Mobile Xray System

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 Class 2 Recall
GE Healthcare Optima Mobile Xray System
see related information
Date Posted July 19, 2012
Recall Status1 Terminated on January 10, 2013
Recall Number Z-1993-2012
Recall Event ID 62527
Product Classification System, X-Ray, Mobile - Product Code IZL
Product GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Code Information Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to the user or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the firmware on the system to address the issue. Your proposed corrective action plan (CAP) (Field Modification Instructions 10865) describes the rework plan that GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved.
Quantity in Commerce 254 units have been shipped to/installed in the U.S.
Distribution Worldwide Distribution (USA) nationwide
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.
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