Z-1638-2014Class II

MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under...

Name: Z-1638-2014 MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-04-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-04-25 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals on 2014-04-25. FDA classified it as Class II and gives the reason as "There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1638-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-25
Posted: 2014-05-20
Terminated: 2014-12-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
Root cause tag: design
FDA root cause: Device Design
Action: A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.
Quantity in commerce: 5
Distribution: Distributed in the states of GA, FL, NY, NV, and MA.
Product codes and lots: (Material number 10549894) with serial numbers 5000 through 5029.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1638-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1638-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-20

Product code MUE

K122286Class IIMammomal InspirationSiemens Medical Solutions USA, Inc. / cleared 2013-02-22

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)