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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
Recall Number Z-0199-2013
Classification Class II
Code Info part numbers: 5555000-3, 5555000-4
Product Distributed Qty 364 total units installed in US
Reason For Recall It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.

Event Detail

Event Id 63597
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution