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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens MAMMOMAT Mammography Systems Recalled for Improper Bus Installation

Agency Publication Date: December 3, 2025
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Summary

Siemens Medical Solutions USA, Inc. is recalling 14 units of its MAMMOMAT Revelation, Inspiration, and Fusion mammography systems because they were sold with bus-installation kits. These operator tables were designed exclusively for stationary use and were not released or intended for installation on mobile buses. Using these systems in a mobile environment may lead to instability or mechanical issues as the equipment was not designed for the stresses of vehicle operation.

Risk

The operator table is not intended for mobile bus installations and was designed for stationary use only. Attempting to use or transport the system in a bus environment could lead to equipment failure or instability, potentially causing injury to healthcare workers or patients.

What You Should Do

  1. This recall affects Siemens MAMMOMAT Revelation, Inspiration, and Fusion mammography systems that were sold together with a bus-installation kit.
  2. Check the model number and serial number printed on your device label to determine if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled system in any mobile or bus-based installation immediately.
  4. Contact Siemens Medical Solutions USA, Inc. or your authorized distributor to arrange for a return, replacement, or correction of the installation components.
  5. Call the FDA at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MAMMOMAT Revelation
Model / REF:
11343300
Serial Numbers:
1296
10550
10572
10606
10608
11511
20140
UDI:
04056869124575

7 units total (3 US, 4 OUS)

Product: MAMMOMAT Inspiration
Model / REF:
10140000
Serial Numbers:
6734
6694
10121
10309
10336
10342
UDI:
04056869009063

6 units total (3 US, 3 OUS)

Product: MAMMOMAT Fusion
Model / REF:
10140000
Serial Numbers:
10559
UDI:
04056869009063

1 unit (OUS only)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97920
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Manufactured In: United States
Units Affected: 3 products (7 units (3 US, 4 OUS); 6 units (3 US, 3 OUS); 1 unit (OUS only))
Distributed To: Arkansas, California, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.