Z-1585-2015Class II

Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for...

Name: Z-1585-2015 Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2015-02-03
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2015-02-03 / Terminated / root cause: labeling and UDI

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer on 2015-02-03. FDA classified it as Class II and gives the reason as "User Manual lacks a description for handling some errors even though the system can be recovered from such errors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1585-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-03
Posted: 2015-05-06
Terminated: 2015-05-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: User Manual lacks a description for handling some errors even though the system can be recovered from such errors
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Fuji Film on 2/3/15, issued a User Notification letter and the recovery procedure were hand carried to the user. A copy of Notification Letter is user's acknowledgement of receipt of the manual .
Quantity in commerce: 1 unit
Distribution: Distributed in HI.
Product codes and lots: Serial Number: 26320119

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1585-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1585-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-06

Product code MUE

K110729Class IIAspire Hd Full-Field Digital Mammography SystemFujifilm Medical Systems U.S.A, Inc. / cleared 2011-09-01

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)