# FDA recall Z-0170-2020

> **GN Otometrics** · Class II · device recall initiated 2019-05-28.

## Product

The ICS CHARTR EP 200

## Reason for recall

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

## Distribution

AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI,  and WV  Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Czech Republic, Denmark, Ecuador, Egypt,  El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guyana, Hong Kong, Hungary, India,   Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Malaysia, Maldives, Mayotte, Mexico, Morocco, Morocco, Netherlands, Netherlands, New Zealand, Norway,  Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia,   Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom,   Viet Nam, and Zimbabwe

## Key facts

- **Recall number:** Z-0170-2020
- **Recalling firm:** GN Otometrics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2019-10-30
- **Termination date:** 2021-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Taastrup, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0170-2020

## Citation

> AI Analytics. FDA recall Z-0170-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0170-2020. Source: US FDA. Licensed CC0.

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