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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 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.
Recall Number Z-0704-2013
Classification Class II
Code Info Definium Model 5000/5220493-2
Product Distributed Qty 312 installed in US
Reason For Recall It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.

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