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Gentherm Medical, LLC: Innercool Coolblue Console, Model STx; Thermal regulating system.

Medical DevicesSource: FDA (device) · Date: 2026-08-26

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Gentherm Medical, LLC
Product
Innercool Coolblue Console, Model STx; Thermal regulating system.
Reason / hazard
Overheating of the 115V CPU board may cause the device to shut down.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-07-13
Code info
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
Product quantity
46 units
Voluntary mandated
Voluntary: Firm initiated
City
Blue Ash
State
OH
Country
United States
Event id
99478
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