MAMMOMAT Inspiration — Class II medical device recall Z-0878-2026
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2025-12-10, distributed nationwide. There were instances where the operator table was sold together with a bus-installation kit. The operator tabl
| Recall number | Z-0878-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2025-10-24 |
| Classified | 2025-12-03 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, IN |
| UPC / GTIN / UDI-DI | 04056869009063 |
| Serial numbers | 10121, 10309, 10336, 10342, 6694, 6734 |
| Model numbers | 10140000 |
Product
MAMMOMAT Inspiration;
Reason for recall
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
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-0878-2026. 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.