United StatesThe MAGNETOM Cima.X Upgrade (Model 11689304; UDI (01)04056869975245(21)237304; Serial Number 237304) sold by Siemens Medical Solutions USA, Inc and distributed in the US (California) and internationally to Australia, Germany and Great Britain is being recalled. The recall is due to a potential ice blockage in the primary and/or auxiliary venting paths of the magnet helium containment venting system that could prevent helium from escaping during a quench, causing pressure build-up, possible rupture of the helium containment system, and a helium leak into the scanning room.
What's being recalled
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Recalling firm: Siemens Medical Solutions USA, Inc, Malvern, PA, United States.
How to identify it
Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
The hazard
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
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
US distribution to California. International distribution to Australia, Germany, Great Britian.
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)