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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

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

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 Letter
Distribution Pattern Nationwide Distribution including NM, WY, FL, MO, MA, and MI.