Z-0170-2020 Class II Terminated
FDA device recall Z-0170-2020 was initiated by GN Otometrics on May 28, 2019 and is designated Class II. 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. The recall status is terminated (terminated April 9, 2021). Affected quantity: 3071 individual units.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- May 28, 2019
- Termination Date
- April 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3071 individual units
Product Description
Reason for Recall
Distribution Pattern
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