FDA Device recall Z-0662-2018
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software…
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software… by Fujifilm Medical Systems U, citing 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 C….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0662-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-04 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | n/a |
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
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.
Identifiers
| code_info | 363AWS. Released Software Versions: V5.1, V6.0. Not Released Software Versions: V5.0, V5.2, V6.1, V7.0. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0662-2018%22
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