FDA-Device2022-01-19Class II
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Gentherm Medical, LLC
Hazard
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
Affected count
484 devices
Manufactured in
12011 Mosteller Rd Fl 3, N/A, Blue Ash, OH, United States
Products
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0496-2022Don't want to check this manually?
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