Blanketrol III, Model 233; Thermal regulating system.
Check against the official notice below — it lists the full affected range.
Gentherm Medical, LLC is recalling the Blanketrol III Model 233 thermal regulating system because the 115V CPU board may overheat and cause the device to shut down. Approximately 9,714 units have been distributed worldwide, including throughout the United States and territories, as well as in Canada, Mexico, Brazil, and several other countries in Central America, South America, the Middle East, and Asia.
The recall affects devices with specific UDI codes (1061303186102, 1061303186107, 1061303186139, 1061303187107, and 1061303187307) and serial numbers ranging from 131-2-00580 through 262-3-20277. The source does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Overheating of the 115V CPU board may cause the device to shut down.
Reason for recall: Overheating of the 115V CPU board may cause the device to shut down. Distribution: 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. Quantity: 9714 units Lot/code info: UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.