Blanketrol® II 115V and Blanketrol® III 115V
Brand(s)
Last updated
Summary
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
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Blanketrol® II 115V | 151-2-01474 | 222S |
| Blanketrol® II 115V | 151-2-01472 | 222S |
| Blanketrol® III 115V | More 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - Cardiovascular
Companies
Gentherm Medical, LLC
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-82413
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