Notice names this product. Gentherm Medical’s Innercool Coolblue Console is named in FDA Class II recall Z-2969-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Overheating of the 115V CPU board may cause the device to shut down. Identifying details: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277. Units affected: 46 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Innercool Coolblue Console
Company / brand
Gentherm Medical
Lot / serial / date codes
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.
Agency product description and boundaries
Innercool Coolblue Console, Model STx; Thermal regulating system.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.