# FDA recall Z-0385-2018

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2017-07-14.

## 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 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.

## Reason for recall

There was a case that the swivel arm went down unintentionally when it was moved up/down.

## Distribution

US Distribution and Internationally to Mexico.

## Key facts

- **Recall number:** Z-0385-2018
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-14
- **Report date:** 2018-01-24
- **Termination date:** 2018-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stamford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0385-2018

## Citation

> AI Analytics. FDA recall Z-0385-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0385-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*