Recall Z-1642-2014 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Fujifilm Medical System USA, Inc.
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
| Date | May 21, 2014 (initiated Jun 29, 2012) |
| Status | Terminated |
| Reason | The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2. |
| Root cause | Radiation Control for Health and Safety Act |
| 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 e |
| Quantity | 14 |
| Distribution | Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.