Fujifilm Smart CR Digital Computed Radiography System Recalled for Power Supply Failure
Fujifilm Medical Systems is recalling 2,062 Smart CR Digital Computed Radiography Systems due to reports of power supply failure.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a power supply failure, which is a functional defect rather than a direct biological or chemical hazard, and no injuries or illnesses are reported in the source text.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 2,062 units of the Smart CR Digital Computed Radiography System, Model Number CR-IR346RU. The recall is being conducted due to reports of failure of the device's power supply.
The affected devices were distributed nationwide. The recall includes all serial numbers of the specified model.
Consumers and healthcare facilities should stop using the affected devices and contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on repair or replacement.
The recalled product
- Product
- Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Hazard
- Affected units
- 2,062
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 (1)
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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