Fujifilm ASPIRE Cristalle Mammography Machine Recall: Unintentional Swivel Arm Movement
Fujifilm recalls ASPIRE Cristalle mammography machines with serial numbers 76221095 or earlier due to risk of unintended swivel arm movement during operation. Affected units may require repair or replacement.
Lower-risk recall
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Contact the company
What happened, in plain English
Fujifilm is recalling certain ASPIRE Cristalle mammography machines because the swivel arm can move down unintentionally when being moved up or down. This could potentially cause the machine to malfunction during use, though serious injury is not reported in the recall. Read more at govinfonow.com/recall/73413-fujifilm-aspire-cristalle-mammography-machine-recall-unintentional-swivel-arm-movement.
Source Summary by GovInfoNow · govinfonow.com/recall/73413-fujifilm-aspire-cristalle-mammography-machine-recall-unintentional-swivel-arm-movement · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0386-2018
Cite this page
“Fujifilm ASPIRE Cristalle Mammography Machine Recall: Unintentional Swivel Arm Movement.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73413-fujifilm-aspire-cristalle-mammography-machine-recall-unintentional-swivel-arm-movement. Based on FDA recall #Z-0386-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0386-2018%22&limit=1).
Why it’s dangerous
The swivel arm can move down unintentionally when the machine is moved up or down. This could cause the machine to malfunction during use, potentially leading to incorrect imaging results or other operational issues. However, the recall does not mention any risk of injury to users.
Who’s affected
Healthcare facilities that own or use the ASPIRE Cristalle (FDR MS-3500) mammography machines with serial numbers 76221095 or earlier are most at risk. Patients using these machines may also be affected if their facility has the recalled model.
How to tell if you have this one
Check the serial number on the ASPIRE Cristalle (FDR MS-3500) mammography machine. Units with serial numbers 76221095 or earlier are affected. The Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000) models are also included in this recall.
- Brand
Fujifilm- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Distribution and Internationally to Mexico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0385-2018 | 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 digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.; FDR MS-2500 made in Japan : S/N- 16640001 or later FDR MS-2500 made in China : S/N- 26860001 or later FDR MS-2000 made in Japan : S/N- 16650001 or later FDR MS-2000 made in China : S/N- 26870001 or later | 20 US |
| Z-0386-2018 | 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 screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.; FDR MS-3500 : S/N- 76221095 or earlier | 15 US 1 OUS |
What to do — step by step
Check Serial Number
Identify the serial number on the ASPIRE Cristalle (FDR MS-3500) machine. Units with serial numbers 76221095 or earlier are affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0386-2018 (July 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0386-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.