Fujifilm Aspire HD Mammography System Recalled for User Manual Error
Fujifilm is recalling one Aspire HD mammography system in Hawaii because the user manual lacks descriptions for handling certain recoverable errors.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to a documentation issue (missing manual instructions) for a recoverable system error, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling one unit of the Aspire HD, Full Field Digital, System, x-Ray, Mammographic (Model: FOR MS-1000). This mammography system is used for the screening and diagnosis of breast cancer.
The recall was initiated because the user manual lacks a description for handling some errors, even though the system can be recovered from such errors. The affected unit has Serial Number 26320119 and was distributed in Hawaii.
Consumers and healthcare facilities with this specific unit should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to proceed.
The recalled product
- Product
- Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Hazard
- Affected units
- 1
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)
- Serial Number: 26320119
Distribution
Distributed in 1 state:
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