FDA-Device2026-08-26Class IIPROCESSING DEFECT
Gentherm Medical Blanketrol II Model 222S thermal regulator recalled for CPU overheating risk
What this means
The Blanketrol II Model 222S thermal regulating system may experience overheating of its 115V CPU board, which can cause the device to shut down unexpectedly. This affects 182 units distributed worldwide. No injuries have been reported.
- Check if your device is a Blanketrol II Model 222S with serial numbers 131-2-00580 through 262-3-20277
- Contact Gentherm Medical, LLC or your healthcare facility for instructions on next steps
- Do not rely on the device until you receive guidance from the manufacturer
The agency's original wording
Hazard
Overheating of the 115V CPU board may cause the device to shut down.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
182 units
Manufactured in
12011 Mosteller Rd Fl 3, Blue Ash, OH, United States
Products
Blanketrol II Model 222S; Thermal regulating system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2968-2026Want us to check the next one for you?
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