Z-0662-2018 Class II Terminated
FDA device recall Z-0662-2018 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Aug 4, 2017 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Apr 1, 2019). Affected quantity: 71 units (68 units Domestic. 3 units Foreign) in total.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 28, 2018
- Initiation Date
- Aug 4, 2017
- Termination Date
- Apr 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 units (68 units Domestic. 3 units Foreign) in total
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide Distribution.
Code Information
363AWS. Released Software Versions: V5.1, V6.0. Not Released Software Versions: V5.0, V5.2, V6.1, V7.0.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0662-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026