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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
GE Healthcare Brivo XR385 DR-F/ X-Ray System		see related information
Date Posted February 26, 2013
Recall Number Z-0761-2013
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
Consumer Instructions No consumer action necessary
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.
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.
 
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