Reported May 28, 2014 · Terminated
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Fujifilm Medical System USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical System USA, Inc. · 419 West Ave · Stamford, CT · 06902-6343
Is this the product you have?
- MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
- Lot codes and dates
- SN
MXA1170108MXA1270262
- SN
- Amount recalled
- 14
Where it was sold
Why it was recalled
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
This product could cause temporary or reversible health problems — stop using it.
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