Aspire Hd Full-Field Digital Mammography System

• • Terminated Z-0659-2018 FDA Class II ·initiated 4 Aug 2017

  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.

• • Terminated Z-2690-2016 FDA Class II ·initiated 9 Jun 2016

  If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.

• • Terminated Z-1585-2015 FDA Class II ·initiated 3 Feb 2015

  User Manual lacks a description for handling some errors even though the system can be recovered from such errors

510(k) Number

K110729 ↗

FDA Product Code

MUE

Device Class

Class II

Regulation

21 CFR Part 892.1715

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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