Z-0386-2018Class II

ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus...

Name: Z-0386-2018 ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2017-07-14
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2017-07-14 / Terminated / root cause: manufacturing process

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000)... on 2017-07-14. FDA classified it as Class II and gives the reason as "There was a case that the swivel arm went down unintentionally when it was moved up/down". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0386-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Posted: 2018-01-17
Terminated: 2018-07-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are 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: There was a case that the swivel arm went down unintentionally when it was moved up/down.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: FUJIFILM sent an Urgent: Medical Device Correction Letter dated July 14, 2017, accompanied by a Customer Feedback form to customers. PLEASE READ AND FOLLOW THE INSTRUCTIONS Please refer to the following page which provides the details of the problem and instructions for actions to be taken. Please follow the instructions in the ACTIONS TO BE TAKEN BY CUSTOMER/USER section. We sincerely regret the inconvenience that this may cause you. FUJIFILM is committed to providing products and services of the highest quality. Your satisfaction with FUJIFILM products and with our response to this issue is very important to us. If you have any questions about this matter, please contact your local FUJIFILM office. For further questions, please call (360) 356-6821.
Quantity in commerce: 15 US 1 OUS
Distribution: US Distribution and Internationally to Mexico.
Product codes and lots: FDR MS-3500 : S/N- 76221095 or earlier

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0386-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0385-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-18
Z-0386-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-18

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)