Z-2969-2026 Class II Ongoing
FDA device recall Z-2969-2026 was initiated by Gentherm Medical, LLC on July 13, 2026 and is designated Class II. Reason for recall: Overheating of the 115V CPU board may cause the device to shut down. The recall status is ongoing. Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- July 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
Innercool Coolblue Console, Model STx; Thermal regulating system.
Reason for Recall
Overheating of the 115V CPU board may cause the device to shut down.
Distribution Pattern
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.
Code Information
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277