United StatesGentherm Medical is recalling three thermal regulating systems — Blanketrol II Model 222S, Innercool Coolblue Console Model STx, and Blanketrol III Model 233 — identified by the listed UDIs and serial numbers (Serial Numbers 131-2-00580 through 262-3-20277 and the UDIs shown). The devices were recalled because overheating of the 115V CPU board may cause the device to shut down.
What's being recalled
Blanketrol II Model 222S; Thermal regulating system.
Innercool Coolblue Console, Model STx; Thermal regulating system.
Blanketrol III, Model 233; Thermal regulating system.
Recalling firm: Gentherm Medical, LLC, Blue Ash, OH, United States.
How to identify it
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277 UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277
The hazard
Overheating of the 115V CPU board may cause the device to shut down.
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 including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.
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)
Canada