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U.S. Department of Health and Human Services

Class 2 Device Recall FullField Digital Mammography Xray System

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  Class 2 Device Recall FullField Digital Mammography Xray System see related information
Date Initiated by Firm August 04, 2017
Create Date February 20, 2018
Recall Status1 Terminated 3 on April 01, 2019
Recall Number Z-0659-2018
Recall Event ID 79078
510(K)Number K110729  
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
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.
Code Information 1000AWS. Released Software Versions: V5.0, V5.1. Not Released Software Versions: V5.2, V6.0, V6.1, V7.0.
Recalling Firm/
Fujifilm Medical Systems U.S.A., Inc.
419 West Ave
Stamford CT 06902-6343
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action The firm, FUJIFILM Medical Systems U.S.A., Inc. (FMSU), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 7/28/2017 to its customers. The letter described the products, problem and actions to be taken. The customers were instructed to please read and follow the instructions in the "ACTIONS TO BE TAKEN BY CUSTOMER/USER" section. If you have an error, contact your local FUJIFILM office; and complete and return the Customer Feedback Form. FUJIFILM service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures.. If you have any questions about this matter, call Recall contact (203) 276-3445 or email: dharaben.desai@fujifilm.com.
Quantity in Commerce 71 units (68 units Domestic. 3 units Foreign) in total
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUE and Original Applicant = FUJIFILM MEDICAL SYSTEMS, USA INC.