FDA Device recall Z-0879-2026
MAMMOMAT Fusion
- FDA Device
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of MAMMOMAT Fusion by Siemens Medical Solutions Usa, citing 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 de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0879-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-24 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
MAMMOMAT Fusion;
Reason
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.
Identifiers
| code_info | Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0879-2026%22
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