Fujifilm Aspire HD Mammography System Recalled for Image ID Error
Fujifilm is recalling Aspire HD 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 potential data loss or overwriting of medical images, which is a significant functional defect but does not involve direct physical injury or death as described in the source text.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 71 units of the Aspire HD Digital Mammography System (FDR MS-l000) and associated acquisition workstations. The recall affects systems using specific software versions (V5.0, V5.1, V5.2, V6.0, V6.1, and V7.0) that were distributed worldwide.
The recall is due to a potential failure in the ID number generation logic. 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 a Picture Archiving and Communication System (PACS), it may overwrite the previously stored image.
The recall covers 68 domestic units and 3 foreign units. The source text does not specify instructions for consumers or healthcare providers regarding immediate actions to take.
The recalled product
- Product
- Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for…
- 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)
- 1000AWS. Released Software Versions: V5.0
- V5.1. Not Released Software Versions: V5.2
- V6.0
- V6.1
- 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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