Z-1694-2013Class II

Siemens Mammomat Inspiration - full-field digital mammography

Name: Z-1694-2013 Siemens Mammomat Inspiration - full-field digital mammography
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-02-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-02-28 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography on 2013-02-28. FDA classified it as Class II and gives the reason as "Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted...". 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-1694-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-28
Posted: 2013-07-11
Terminated: 2014-02-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this iss
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued an Update Instructions XP031/12/S by letter to the affected customers. For affected sites, a Siemens Service Engineer will inspect the unit and make any adjustments needed. Following the inspection and adjustments, a proper calibration will be completed. For questions call 610-448-3237 and 610-446-4634.
Quantity in commerce: 3
Distribution: United States Nationwide Distribution in the states of ND, OH and SC.
Product codes and lots: Model number 10140000, serial numbers 3118, 3243 and 3309

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1694-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1694-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)