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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

Product Description EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Recall Number Z-2072-2012
Classification Class II
Code Info All associated Serial Numbers
Product Distributed Qty 12 EOS Systems installed in the US
Reason For Recall 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.

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 Letter
Distribution Pattern Nationwide distribution