Fujifilm Medical Systems U.S.A., Inc.: 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.

Recall number

Z-0662-2018

Recalling firm

Fujifilm Medical Systems U.S.A., Inc.

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.

Status

Terminated

Initiated

2017-08-04

Posted

not on file

Terminated

2019-04-01

Reason

FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS 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.

Root cause

Software design

Action

The firm, FUJIFILM Medical Systems U.S.A., Inc. (FMSU), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 7/28/2017 to its customers. The letter described the products, problem and actions to be taken. The customers were instructed to please read and follow the instructions in the "ACTIONS TO BE TAKEN BY CUSTOMER/USER" section. If you have an error, contact your local FUJIFILM office; and complete and return the Customer Feedback Form. FUJIFILM service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures.. If you have any questions about this matter, call Recall contact (203) 276-3445 or email: dharaben.desai@fujifilm.com.

Quantity

71 units (68 units Domestic. 3 units Foreign) in total

Distribution

Worldwide Distribution.

Lot, serial or model codes

363AWS. Released Software Versions: V5.1, V6.0. Not Released Software Versions: V5.0, V5.2, V6.1, V7.0.

510(k) numbers

not on file

PMA numbers

P050014

Product code

MUE

Firm FEI

1000513161

Firm city

Stamford

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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