Fujifilm Aspire Cristalle Mammography Machine Recalled for Swivel Arm Defect
Fujifilm is recalling Aspire Cristalle mammography machines because the swivel arm may move down 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 mechanical defect in a medical device that poses a risk of harm (injury), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling the ASPIRE Cristalle (FDR MS-3500) mammography machine. The recall involves 15 units in the United States and 1 unit in Mexico.
The recall is being issued because there was a case where the swivel arm went down unintentionally when it was moved up or down. This defect could pose a risk of injury to patients or operators.
Affected units are identified by serial number 76221095 or earlier. Users of these devices should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to address the issue.
The recalled product
- Product
- ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used 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 (1)
- FDR MS-3500 : S/N- 76221095 or earlier
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 →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- 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
Similar recalls
- ModerateFujifilm ASPIRE Cristalle Mammography Systems Recalled for Image ID Errors
FDA (Devices) · 2018-02-28
- ModerateFujifilm Digital Mammography System Recalled for Biopsy Workflow Error
FDA (Devices) · 2016-09-07
- ModerateFujifilm Aspire HD Mammography System Recalled for Image ID Error
FDA (Devices) · 2018-02-28
- ModerateFujifilm Recalls Digital Mammography Systems Due to Image ID Error
FDA (Devices) · 2018-02-28
- LowFujifilm Aspire HD Mammography System Recalled for User Manual Error
FDA (Devices) · 2015-05-13
- HighFujifilm Recalls Mammography Software Due to Potential Image Overwrite Error
FDA (Devices) · 2018-02-28