Device product
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Z-0496-2022
Product summary
- Event
- Event 89193
- Status
- Terminated
- Classification
- Class II
- Quantity
- 484 devices
- Official record key
device-enforcement:Z-0496-2022
Official wording
Reason: This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Code information: UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
Derived failure modes
-
Unknown
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.