FDA Medical devices recall ·
MAMMOMAT Revelation recall
- Recall number
- Z-0877-2026
- Date
- (initiated October 24, 2025)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7 units (3 US, 4 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MAMMOMAT Revelation;
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;
Distribution
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
States: Arkansas California New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0877-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.