Z-0086-2015Class II

Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography...

Name: Z-0086-2015 Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-09-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-09-18 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic... on 2014-09-18. FDA classified it as Class II and gives the reason as "The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough...". 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-0086-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-18
Posted: 2014-10-17
Terminated: 2015-02-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for 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: The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken.
Quantity in commerce: 3
Distribution: US Distribution in states of: NY, VA, and MA.
Product codes and lots: material #10140000, with serial numbers: 5018 3849 5042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0086-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0086-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-17

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)