Siemens Medical Solutions USA, Inc: Medical Device Recall in 2025 - (Recall #: Z-0877-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

MAMMOMAT Revelation;

Product Classification:

Class II

Date Initiated: October 24, 2025

Date Posted: December 10, 2025

Recall Number: Z-0877-2026

Event ID: 97920

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.

Status: Ongoing

Product Quantity: 7 units (3 US, 4 OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated