GN Otometrics The ICS CHARTR EP 200 recall — FDA Z-0170-2020
There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
Overview of recall records associated with GN Otometrics, including dates, categories and classifications where available.
Classification mix: Class II: 2.
There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
This page summarizes recall records in which the official source identifies GN Otometrics as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.