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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Recall Number Z-1642-2014
Classification Class II
Code Info SN: MXA1170108, MXA1270262
Product Distributed Qty 14
Reason For Recall The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.

Event Detail

Event Id 67958
Product Type Devices
Status Ongoing
Recalling Firm Fujifilm Medical System USA, Inc.
City Stamford
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
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