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.
What this means for you
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 digita
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Fujifilm Medical Systems U.S.A., Inc.
See all →- HighSynapse Cardiovascular software may incorrectly reuse patient database identifiers
FDA (Devices) · 2021-06-09
- HighFujifilm Medical Systems Recalls Potentially Defective Wako Chip Cassettes
FDA (Devices) · 2021-04-21
- HighFujifilm Synapse PACS Recalled for Potential Wrong Patient Information Display
FDA (Devices) · 2021-04-14
- ModerateFujifilm Synapse PACS Software Recalled for Clinical Reporting Errors
FDA (Devices) · 2021-02-03
- ModerateFujifilm Recalls Wako HDL-C/LDL-C Calibrator Due to Labeling Error
FDA (Devices) · 2021-02-03
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28