Device recall
Innercool Coolblue Console, Model STx; Thermal regulating system.
- Recall number
- Z-2969-2026
- Event id
- 99478
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Gentherm Medical, LLC
- Report date
- Aug 26, 2026
- Initiated
- Jul 13, 2026
- Center classification date
- Aug 14, 2026
- Reason
- Overheating of the 115V CPU board may cause the device to shut down.
- Quantity
- 46 units
- Code info
- UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Blue Ash, OH, United States