Z-0661-2018Class II

ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500)...

Name: Z-0661-2018 ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500)...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2017-08-04
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2017-08-04 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that... on 2017-08-04. FDA classified it as Class II and gives the reason as "FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to...". 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-0661-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-04
Posted: 2018-02-20
Terminated: 2019-04-01
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) 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: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS 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.
Root cause tag: software
FDA root cause: 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: [email protected].
Quantity in commerce: 71 units (68 units Domestic. 3 units Foreign) in total
Distribution: Worldwide Distribution.
Product codes and lots: 3000AWS. Released Software Versions: V5.1, V5.2, V6.0, V6.1, V7.0. Not Released Software Versions: V5.0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0661-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0659-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0660-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0661-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0662-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20

Product code MUE

K133972Class IIAspire CristalleFujifilm Medical Systems U.S.A, Inc. / cleared 2014-03-25

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)