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U.S. Department of Health and Human Services

Class 2 Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY)

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  Class 2 Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY) see related information
Date Initiated by Firm June 09, 2016
Create Date August 30, 2016
Recall Status1 Terminated 3 on September 19, 2016
Recall Number Z-2690-2016
Recall Event ID 74525
510(K)Number K113284  K110729  
Product Classification Full field digital,system,x-ray,mammographic - Product Code MUE
Product FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY)

The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), 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 26330437 and 17230408 
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
419 West Ave
Stamford CT 06902-6343
For Additional Information Contact
203-324-2000
Manufacturer Reason
for Recall		 If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.
FDA Determined
Cause 2		 Software design
Action The firm, Fujifilm, sent a "FIELD SAFETY NOTICE" letter dated June 9, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to read and follow the instructions in the letter; call your local service representative, in case an error occurs, and complete and return the Customer Feedback Form via fax (203)-251-7862. Both affected systems will be corrected via on-site visits by FMSU Customer Service Engineers. If you have any questions about this matter, please contact the Product Manager, Women's Health directly at (303)-888-4549 or call your local FUJIFILM office.
Quantity in Commerce 2 Units
Distribution US Distribution to: NC and HI.
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 = FUJI FILM MEDICAL SYSTEMS
510(K)s with Product Code = MUE and Original Applicant = FUJIFILM MEDICAL SYSTEMS, USA INC.
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