Fujifilm Recalls Digital Mammography Systems Due to Image ID Error
Fujifilm is recalling 71 digital mammography systems because a software error may cause duplicate image IDs, potentially overwriting stored images.
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. The hazard involves data integrity (image overwriting) rather than direct physical injury or death, fitting the criteria for moderate severity.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 71 units of Aspire HD Plus and Aspire HD-s digital mammography systems. The recall affects 68 domestic units and 3 foreign units distributed worldwide.
The recall is due to a potential software failure in the acquisition workstations (FDR-1000AWS, FDR-2000AWS, FDR-3000AWS, and CR-IR363AWS). In rare cases, the system may assign the same unique ID number to a new set of images that was already assigned to a previous set. If an image with this duplicate ID is transmitted to the Picture Archiving and Communication System (PACS), it may overwrite the previously stored image.
The affected software versions include V5.0, V5.1, V5.2, V6.0, V6.1, and V7.0. Healthcare facilities using these systems should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening…
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
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 (5)
- 2000AWS. Released Software Versions: V5.1
- V6.0
- V6.1. Not Released Software Versions: V5.0
- V5.2
- V7.0.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Fujifilm Medical Systems U.S.A., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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