Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Reported: January 19, 2022 Initiated: November 22, 2021 #Z-0496-2022
Product Description
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Reason for Recall
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Details
- Recalling Firm
- Gentherm Medical, LLC
- Units Affected
- 484 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
- Location
- Blue Ash, OH
Frequently Asked Questions
What product was recalled? ▼
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193. Recalled by Gentherm Medical, LLC. Units affected: 484 devices.
Why was this product recalled? ▼
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0496-2022.
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