Mammomat Inspiration with Tomosynthesis functionality — Class II medical device recall Z-0888-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-03-02, distributed nationwide. A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nea
| Recall number | Z-0888-2016 |
|---|---|
| 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 | 2016-02-12 |
| Classified | 2016-02-25 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 76 units |
| Model numbers | 10140000 |
Product
Mammomat Inspiration with Tomosynthesis functionality
Reason for recall
A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted. The syste
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-0888-2016. 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.