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 di

Recalled February 28, 2018 · FDA recall Z-0659-2018 · Fujifilm Medical Systems U.S.A

Hazard

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. · FDA Class II

Units

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

Sold at

Worldwide Distribution.

Description

Product

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.

Manufacturer(s)

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

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →