CanadaGentherm Medical Blanketrol II 115V (model 222S) with serial numbers 151-2-01474, 151-2-01472, 114-2-00258, 131-2-00535, 124-2-00447, 124-2-00490, 114-2-00259, and Blanketrol III 115V (model 233) with serial numbers of more than 10 numbers (contact the manufacturer) are affected. Complaints of overheated circuit boards in 0.53% of devices can stop the board and cause the device to shut down at startup or during use; users may continue to use the devices but are advised to have an alternative means of therapy available and to contact the manufacturer for more information.
What's being recalled
Companies: Gentherm Medical, LLC.
How to identify it
Affected products: Blanketrol® II 115V; Lot or serial number: 151-2-01474; Model or catalogue number: 222S
Affected products: Blanketrol® II 115V; Lot or serial number: 151-2-01472; Model or catalogue number: 222S
Affected products: Blanketrol® II 115V; Lot or serial number: 114-2-00258; Model or catalogue number: 222S
Affected products: Blanketrol® II 115V; Lot or serial number: 131-2-00535; Model or catalogue number: 222S
Affected products: Blanketrol® II 115V; Lot or serial number: 124-2-00447; Model or catalogue number: 222S
Affected products: Blanketrol® II 115V; Lot or serial number: 124-2-00490; Model or catalogue number: 222S
Affected products: Blanketrol® II 115V; Lot or serial number: 114-2-00259; Model or catalogue number: 222S
Affected products: Blanketrol® III 115V; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 233
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States