# FDA recall Z-0662-2018

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2017-08-04.

## Product

Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS)     The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

## Reason for recall

FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system.  The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a  unique ID number to every image study but very rarely, with the acquisition workstation software versions,  VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images  that was already assigned to the previous set of images due to the error in ID number generation logic. If an  Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already  stored on PACS.

## Distribution

Worldwide Distribution.

## Key facts

- **Recall number:** Z-0662-2018
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-04
- **Report date:** 2018-02-28
- **Termination date:** 2019-04-01

- **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-0662-2018

## Citation

> AI Analytics. FDA recall Z-0662-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0662-2018. Source: US FDA. Licensed CC0.

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