Z-0523-2015Class II

Mammomat Inspiration system

Name: Z-0523-2015 Mammomat Inspiration system
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-10-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-10-28 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals... on 2014-10-28. FDA classified it as Class II and gives the reason as "It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0523-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-28
Posted: 2014-12-06
Terminated: 2015-07-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.
FDA root cause: Use error
Action: A safety advisory notice, dated October 28, 2014, was sent to users that identified the product, problem, and actions to be taken to prevent risk to patients and users. Siemens technicians werre instructed to contact customers to schedule a field modification.
Quantity in commerce: 3
Distribution: US Nationwide Distribution in the state of: WV, NY, and FL..
Product codes and lots: model number: 10140000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0523-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0523-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-05

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)