Recall Z-0662-2018— Fujifilm Medical Systems U.S.A., Inc.

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2017-08-04, terminated 2019-04-01. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm

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

Classification

Class II

Status

Terminated

Initiated

2017-08-04

Terminated

2019-04-01

Firm location

Stamford, CT, United States

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