MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator

FDA device recall Z-1642-2014 · posted 2014-05-21 · Terminated

Recall details

Recalling firm

Fujifilm Medical System USA, Inc.

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 taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

MUE

Quantity affected

14

Distribution

Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.

Date initiated

2012-06-29

Date posted

2014-05-21

Date terminated

2018-06-01

Location

Stamford, CT