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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Event Detail

Event ID 62946
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution -- USA (nationwide) Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body. Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6. Class II Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed. 254 total in the US Z-2256-2012
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6. Class II Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed. 254 total in the US Z-2255-2012
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