Mammomat Inspiration system: Product Usage: mammography exams — Class II medical device recall Z-0523-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-12-17, distributed nationwide. It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) a
| Recall number | Z-0523-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2014-10-28 |
| Classified | 2014-12-05 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-07-20 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Model numbers | 10140000 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0523-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.