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Siemens Medical Solutions USA, Inc: MAMMOMAT Revelation;

Medical DevicesSource: FDA (device) · Date: 2025-12-10

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Medical Solutions USA, Inc
Product
MAMMOMAT Revelation;
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Recall initiated
2025-10-24
Code info
Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;
Product quantity
7 units (3 US, 4 OUS)
Voluntary mandated
Voluntary: Firm initiated
City
Malvern
State
PA
Country
United States
Event id
97920
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