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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Event Detail

Event ID 62621
Product Type Devices
Status Ongoing
Recalling Firm Eos Imaging Inc
City Cambridge
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination. All associated Serial Numbers Class II It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode. 12 EOS Systems installed in the US Z-2072-2012