Fujifilm FDR Go Plus X-ray System Recalled for Software Glitch
Fujifilm is recalling 174 FDR Go Plus mobile X-ray systems because a graphics driver issue may cause the device to display a Blue Screen of Death.
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 temporary or medically reversible adverse health consequence. The specific hazard is a software crash (Blue Screen of Death) that interrupts device operation, fitting the criteria for a moderate severity issue without reported injuries.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 174 units of the FDR Go Plus mobile X-ray system. The recall was initiated because the device's graphics driver may cause the appearance of a Blue Screen of Death (BSoD).
The affected units were distributed nationwide. The recall applies to all serial numbers of this specific model.
Consumers and healthcare facilities should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to address this software issue.
The recalled product
- Product
- Fujifilm FDR Go Plus mobile X-ray system
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Hazard
- Affected units
- 174
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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