Class IIDeviceOngoing

Gentherm Medical, LLC

Innercool Coolblue Console, Model STx; Thermal regulating system.

Reason for recall

Overheating of the 115V CPU board may cause the device to shut down.

Details

Recall number: Z-2969-2026
Event ID: 99478
Recall initiated: Jul 13, 2026
Classified: Aug 14, 2026
Reported: Aug 26, 2026
Quantity: 46 units
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.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Blue Ash, OH, United States
Lot / code info: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277