MAMMOMAT Revelation recallZ-0877-2026 · Siemens Medical Solutions USA, Inc · initiated Oct 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component design/selection
What the company is doing
On October 24, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please ensure that this safety advisory is retained in your product related records appropriately. Please keep this information until the corrective measures have been finalized. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If this device/equipment is no longer in your possession, please forward this Customer Safety Advisory Notice to the new owner of this device. If applicable, please inform us about the new owner of the device.
Recall details
- Recall number
- Z-0877-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 24, 2025
- Posted by the FDA
- Dec 3, 2025
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 7 units (3 US, 4 OUS)
- Product code
- MUE
- FDA submissions
- K193166
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Product description
MAMMOMAT Revelation;
Code information (models, lots, serial numbers)
Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MAMMOMAT Revelation 11343300Siemens Healthcare GmbH · Full field digital,system,x-ray,mammographic1 recall11 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97920).
- Z-0878-2026 · Open, ClassifiedMAMMOMAT Inspiration;
- Z-0879-2026 · Open, ClassifiedMAMMOMAT Fusion;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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