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Electri-Cool ll 767Recalls & reported problems

Gentherm Medical, LLC · The Electri-Cool® II System is intended to provide cold therapy. · Class 2

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 22, 2021Terminated

    This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

    Z-0496-2022 · Root cause: Device Design · FDA record ↗

Other Pack, Hot Or Cold, Water Circulating devices

All Pack, Hot Or Cold, Water Circulating devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.