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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Brivo XR385 DRF/ XRay System

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 Class 2 Recall
GE Healthcare Brivo XR385 DRF/ XRay System
see related information
Date Posted February 26, 2013
Recall Status1 Terminated on December 05, 2013
Recall Number Z-0761-2013
Recall Event ID 64226
Product Classification System, X-Ray, Film Marking, Radiographic - Product Code JAC
Product GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Code Information Model Number : 5271997
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 software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product 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 issue or bring the product into compliance with each applicable Federal and IEC standard in accordance with a planto be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the software on the system to address the issue. Contact Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.
Quantity in Commerce 9 units installed in US
Distribution Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
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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