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U.S. Department of Health and Human Services

Class 2 Device Recall The MXR35 Xray Generator's.

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 Class 2 Recall
The MXR35 Xray Generator's.
see related information
Date Posted May 21, 2014
Recall Status1 Open
Recall Number Z-1642-2014
Recall Event ID 67958
Premarket Notification
510(K) Number
K121674 
Product Classification Full Field Digital,System,X-Ray,Mammographic - Product Code MUE
Product MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Code Information SN: MXA1170108, MXA1270262
Recalling Firm/
Manufacturer
Fujifilm Medical System USA, Inc.
419 West Ave
Stamford, Connecticut 06902-6343
Manufacturer 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.
Action Fujifilm will replace the violative labels with replacement labels provided by DRGEM, to bring the X-ray generator into compliance. You stated that you expect for all nine installed units to be corrected by the end of May 2014. The seven units in the Stamford, CT warehouse will be corrected when the generators are delivered to customer sites. Under 21 CFR 1003.31(c)(2), this exemption is granted subject to the following conditions: 1. You must correct the missing certification statement for all units shipped into the US within the timeline you specified, by the end of May 2014. 2. You must ensure that all future units that will be delivered and installed in the US will be in compliance with the labeling requirement, per 21 CFR 1010.2.
Quantity in Commerce 14
Distribution Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = MUE and Original Applicant = FUJIFILM MEDICAL SYSTEM U.S.A., INC.
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