Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. Recalled by Fujifilm Medical System USA, Inc. Due to The MXR-35 X-ray Generator's labeling did not include...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fujifilm Medical System USA, Inc. directly.
Affected Products
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Quantity: 14
Why Was This Recalled?
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
Where Was This Sold?
This product was distributed to 2 states: KY, TX
About Fujifilm Medical System USA, Inc.
Fujifilm Medical System USA, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report