United StatesMAMMOMAT Revelation, MAMMOMAT Inspiration, and MAMMOMAT Fusion imaging systems identified by model numbers 11343300 (UDI‑DI 04056869124575) and 10140000 (UDI‑DI 04056869009063) with system serial numbers 1296, 10550, 10572, 10606, 10608, 11511, 20140, 6734, 6694, 10121, 10309, 10336, 10342 and 10559 are affected. They were recalled because the operator table was sold together with a bus‑installation kit even though the table is not intended and not released for bus installations and was designed for stationary operation only.
What's being recalled
MAMMOMAT Revelation;
MAMMOMAT Inspiration;
MAMMOMAT Fusion;
Recalling firm: Siemens Medical Solutions USA, Inc, Malvern, PA, United States.
How to identify it
Model Number: 11343300; UDI-DI: 04056869124575; System Serial Numbers: 1296, 10550, 10572, 10606, 10608, 11511, 20140; Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 6734, 6694, 10121, 10309, 10336, 10342; Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 10559;
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)