Fujifilm Recalls 14 MXR-35 X-ray Generators for Missing Certification Labeling
Fujifilm Medical System USA is recalling 14 MXR-35 Diagnostic X-ray High Voltage Generators because the labeling did not include the certification statement required by 21 CFR Part 10 10.2.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (missing certification statement) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall or minor labeling error.
Plain-English summary
Fujifilm Medical System USA, Inc. is recalling 14 units of the MXR-35 Diagnostic X-ray High Voltage Generator. The product was manufactured by DRGEM Corporation. The recall was initiated because the product labeling did not include the certification statement required by 21 CFR Part 10 10.2.
The affected units were distributed worldwide, including in the United States (specifically Texas and Kentucky) and internationally to China. The specific serial numbers for the recalled units are MXA1170108 and MXA1270262.
This recall is classified as Class II by the FDA. The source text does not report any illnesses, injuries, or deaths associated with this labeling deficiency. Users of these devices should contact the recalling firm for further instructions regarding the labeling correction.
The recalled product
- Product
- MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
- Manufacturer
- Fujifilm Medical System USA, Inc.
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- SN: MXA1170108
- MXA1270262
Distribution
Related recalls
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02