Z-2690-2016Class II

FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm...

Name: Z-2690-2016 FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2016-06-09
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2016-06-09 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR... on 2016-06-09. FDA classified it as Class II and gives the reason as "If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2690-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-09
Posted: 2016-08-30
Terminated: 2016-09-19
Recalling firm: FUJIFILM Healthcare Americas Corporation
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.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 26330437 and 17230408

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2690-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2690-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-30

Product code MUE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)