Fujifilm Digital Mammography System Recalled for Biopsy Workflow Error
Fujifilm is recalling two Aspire HD Digital Mammography Systems because an aborted stereo biopsy may cause an error that prevents the system from operating properly.
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 the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling two units of the FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY). The affected units were distributed in North Carolina and Hawaii.
The recall was initiated because if an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly. This issue affects the system's ability to function correctly following a specific procedural interruption.
Healthcare facilities that have these specific units should contact the recalling firm for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be…
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Hazard
- Affected units
- 2
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)
- 26330437 and 17230408
Distribution
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