Z-1118-2017Class II

Mammomat Inspiration full, field digital,system,x-ray,mammographic

Name: Z-1118-2017 Mammomat Inspiration full, field digital,system,x-ray,mammographic
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-01-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-01-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening... on 2017-01-11. FDA classified it as Class II and gives the reason as "Software error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1118-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Posted: 2017-01-31
Terminated: 2017-11-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: 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: Software error
Root cause tag: software
FDA root cause: Software design
Action: Siemens mailed a Customer Safety Advisory Notice (CSAN) letter dated January 11, 2017 to affected customers. The letter identified the affected product, the potential risks and the steps to take to avoid the risks associated with the issue. The letter also stated Siemens will release a field modification (software update) to resolve the issue as soon as possible. The new software will be provided to affected customers free of charge.
Quantity in commerce: 55 units
Distribution: United States Nationwide Distribution
Product codes and lots: Device Model # 10140000 Serial Numbers: 4709 6616 6571 6602 6761 6573 4520 4556 6567 6424 6306 6757 6560 6524 6412 6442 5018 6675 8038 6575 6045 3122 6871 3243 4571 6259 6469 6676 6474 6640 6452 6561 6801 2098 4161 6483 6344 6288 6594 8002 6610 6394 4018 6502 6080 4214 6893 6093 3118 6601 5042 6246 3088 4525 6870

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1118-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-31

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)