MAMMOMAT Fusion;
Reported: December 10, 2025 Initiated: October 24, 2025 #Z-0879-2026
Product Description
MAMMOMAT Fusion;
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 1 unit (OUS only)
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
MAMMOMAT Fusion;. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1 unit (OUS only).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2025. Severity: Moderate. Recall number: Z-0879-2026.
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