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U.S. Department of Health and Human Services

Class 2 Device Recall GE Automatic Mobile XRay Systems

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 Class 2 Recall
GE Automatic Mobile XRay Systems
see related information
Date Posted April 24, 2012
Recall Status1 Terminated on January 16, 2014
Recall Number Z-1399-2012
Recall Event ID 61553
Product Classification System, X-Ray, Mobile - Product Code IZL
Product GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. General Electric, Waukesha, WI Indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
Code Information All associated serial numbers.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product, related to the light field to x-ray field edge alignment.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action GE Healthcare will issue an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect and related hazards, along with the safety instructions, affected product, and product correction GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with an approved plan, the details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the external tube port on the source assembly to address the issue. Questions or concerns can be directed to the Call Center at 800-437-1171 or your local GE Healthcare Service Representative.
Quantity in Commerce 130 installed in US
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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