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CLASS II · ModerateFDA

Siemens Medical Solutions USA, Inc recalls MAMMOMAT Inspiration

📅 Oct 24, 2025 · 📍 Nationwide
Recalling company
Siemens Medical Solutions USA, Inc
Product
MAMMOMAT Inspiration;
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 24, 2025
Reported
Dec 10, 2025
Distribution
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Status
Ongoing
Quantity
6 units (3 US, 3 OUS)
Lot / codes
Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 6734, 6694, 10121, 10309, 10336, 10342;
Company location
Malvern, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-0878-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0878-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.