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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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