Gentherm Medical Recalls Innercool Coolblue Console Due to Overheating Risk
Gentherm Medical is recalling 46 Innercool Coolblue Console units because overheating of the 115V CPU board may cause the device to shut down.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (device shutdown) where no injuries or illnesses have been reported, fitting the criteria for a High severity rating.
Plain-English summary
Gentherm Medical, LLC is recalling 46 units of the Innercool Coolblue Console, Model STx, a thermal regulating system. The recall is due to a defect where overheating of the 115V CPU board may cause the device to shut down.
The affected units were distributed worldwide, including US nationwide distribution in territories such as Puerto Rico, and in countries including Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago. The specific units involved have UDI 1061303186165 and serial numbers ranging from 131-2-00580 through 262-3-20277.
Consumers and healthcare facilities should check their inventory for these specific serial numbers. If a unit is found, it should be removed from service and the recalling firm contacted for instructions on return or replacement.
The recalled product
- Product
- Innercool Coolblue Console, Model STx; Thermal regulating system.
- Manufacturer
- Gentherm Medical, LLC
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
Distribution
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