Z-1642-2014Class II

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

Name: Z-1642-2014 MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Creator: Fujifilm Medical System USA, Inc.
Published: 2012-06-29
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2012-06-29 / Terminated / root cause: labeling and UDI

FDA source

Fujifilm Medical System USA, Inc. began a recall of MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator on 2012-06-29. FDA classified it as Class II and gives the reason as "The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1642-2014
Classification: Class II
Status: Terminated
Initiated: 2012-06-29
Posted: 2014-05-21
Terminated: 2018-06-01
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
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.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: SN: MXA1170108, MXA1270262

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1642-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1642-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-21

Product code MUE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)