GN Otometrics Recalls ICS CHARTR EP 200 Due to Electrical Shock Risk

Plain-English summary

GN Otometrics is recalling 3,071 individual units of the ICS CHARTR EP 200. The recall is due to a risk of exposure to undergrounded electrical surfaces, which may result in electrical shock to the healthcare professional or patient.

The affected devices are distributed across numerous U.S. states, including 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. The devices have also been distributed internationally to countries including Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guyana, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Maldives, Mayotte, Mexico, Morocco, 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.

Healthcare professionals and patients should stop using the affected ICS CHARTR EP 200 units immediately to avoid the risk of electrical shock. The recall number is Z-0170-2020.

The recalled product

Product

The ICS CHARTR EP 200

Manufacturer

GN Otometrics

Category

Medical Device — Audiology

Hazard

• electrical-shock

Affected units

3,071

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls