FDA Device recall Z-0888-2016
Mammomat Inspiration with Tomosynthesis functionality
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Mammomat Inspiration with Tomosynthesis functionality by Siemens Medical Solutions Usa, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0888-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-12 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Mammomat Inspiration with Tomosynthesis functionality
Reason
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
Identifiers
| code_info | Model number: 10140000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0888-2016%22
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