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Recall Observatory FDA recall evidence

Device product

MAMMOMAT Revelation;

Z-0877-2026

October 24, 2025

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 97920
Status
Ongoing
Classification
Class II
Quantity
7 units (3 US, 4 OUS)
Official record key
device-enforcement:Z-0877-2026

Official wording

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.

Code information: Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;

Distribution pattern: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.