Blanketrol® II 115V and Blanketrol® III 115V

Gentherm Medical has received complaints of overheated circuit boards in 0.53% of distributed devices. Overheating can cause the circuit board to stop operating, which may result in a device that shuts down at startup or during use on a patient.

Based on the low probability of harm, and absence of reported harm, associated with this issue, users may continue to use the device. In an abundance of caution, it is recommended to have an alternative means of providing therapy available.