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Fujifilm Medical System USA, Inc. recalls MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Recalled May 28, 2014 · FDA recall Z-1642-2014 · Fujifilm Medical System USA
Hazard
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2. · FDA Class II
Units
14
Sold at
Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
Description
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
Product
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Manufacturer(s)
Fujifilm Medical System USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →