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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Recall Number Z-1993-2012
Classification Class II
Code Info Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw
Product Distributed Qty 254 units have been shipped to/installed in the U.S.
Reason For Recall GE Healthcare hos become aware of o software issue on the interfoce of the mobile radiogrophic product, Optima XR200amx, ond Optima XR22Oamx reloted to Visual indicotion as mandoted by the US Code of Federol Regulations (21CFR) and IEC 60601-1-3.

Event Detail

Event Id 62527
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution (USA) nationwide