Fujifilm Aspire HD Plus Mammography Machines Recalled for Swivel Arm Defect
Fujifilm is recalling Aspire HD Plus and HD-s mammography machines because the swivel arm may drop unintentionally.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a mechanical failure could cause injury, but the source text does not explicitly report that injuries or illnesses have occurred.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling the Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000) digital mammography systems. These machines are used for the screening and diagnosis of breast cancer.
The recall is due to a defect where the swivel arm may go down unintentionally when it is moved up or down. This issue was identified in a specific case involving the equipment.
The affected units were distributed in the United States and Mexico. Consumers and healthcare facilities should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions regarding the recall.
The recalled product
- Product
- Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field…
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Affected units
- 20
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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