FDA recall Z-0170-2020

GN Otometrics · Class II · device

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

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

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