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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64226
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-03
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including NM, WY, FL, MO, MA, and MI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System Model Number : 5271997 Class II 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. 9 units installed in US Z-0761-2013