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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 64134
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
GE Healthcare Definium 5000/5220493-2 X-Ray System .This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts. Definium Model 5000/5220493-2 Class II It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000. 312 installed in US Z-0704-2013
GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts. Definium Model 5000/5220493 Class II It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000. 312 installed in US Z-0703-2013
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