MAMMOMAT Inspiration — Class II medical device recall Z-1638-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-05-28, distributed in FL, GA, MA, NV, NY. There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the con
| Recall number | Z-1638-2014 |
|---|---|
| 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 | 2014-04-25 |
| Classified | 2014-05-20 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2014-12-15 |
| Distributed | FL, GA, MA, NV, NY |
| Quantity | 5 |
| Reason classes | device malfunction |
| Serial numbers | 5000 |
Product
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Reason for recall
There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
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-1638-2014. 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.