Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The ICS CHARTR EP 200 Recalled by GN Otometrics Due to There is a risk to the healthcare professional...

Date: May 28, 2019
Company: GN Otometrics
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GN Otometrics directly.

Affected Products

The ICS CHARTR EP 200

Quantity: 3071 individual units

Why Was This Recalled?

There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.

Where Was This Sold?

This product was distributed to 47 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC

Affected (47 states)Not affected

About GN Otometrics

GN Otometrics has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report