Health Products

Blanketrol® II 115V and Blanketrol® III 115V

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use, Health products - Medical devices - Cardiovascular
Product: Blanketrol® II 115V and Blanketrol® III 115V
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Blanketrol® II 115V151-2-01474222S
Blanketrol® II 115V151-2-01472222S
Blanketrol® III 115VMore than 10 numbers, contact manufacturer.233

Issue

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.

Get told about the next health product recall.
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