Fujifilm Medical Systems U.S.A., Inc. recalls Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digi…

Recall date

August 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0659-2018

FDA classification

Class II

Brand / firm

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

Sold / distributed

Worldwide Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.