Siemens Mammomat Inspiration mammography systems — Class II medical device recall Z-0086-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-10-29, distributed in MA, NY, VA. The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch w
| Recall number | Z-0086-2015 |
|---|---|
| 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 | 2014-09-18 |
| Classified | 2014-10-17 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-02-24 |
| Distributed | MA, NY, VA |
| Quantity | 3 |
| Serial numbers | 3849, 5018, 5042 |
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.
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
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-0086-2015. 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.