The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0170-2020·Announced 2019-10-30

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

GN Otometrics is recalling 3,071 ICS CHARTR EP 200 units because undergrounded electrical surfaces may cause electrical shock to patients or healthcare professionals.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of electrical shock, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

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
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.

Lot numbers (20)

  • TDH49
  • 115/60 05713315006449
  • 8-04-12734 ICS Chartr EP 200 2Ch
  • Insert&Bone 05713315006173
  • 8-04-12731 ICS Chartr EP 200 2ch
  • 230 VAC (50 Hz) Incl. Insert Earphone
  • TDH49 Earhone w cable
  • Bone Conduction Transducer (B71)
  • 8-04-12730 ICS Chartr EP 200 2ch
  • 8-04-12729 ICS Chartr EP 200 2Ch
  • Bone Conduction Transducer (B71) and VEMP Monitor Kit 05713315006388
  • 8-04-12727 ICS Chartr EP 200 2Ch
  • TDH49 Earhone w cable and VEMP Monitor Kit 05713315006418
  • 8-04-12725 ICS Chartr EP 200 2ch
  • VEMP Monitor Kit
  • 8-04-12723 ICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone
  • 8-04-12720 ICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone
  • 8-04-12711 1073 ICS Chartr EP 200 w/o Vemp
  • CN only N/A
  • 8-04-12710 1073 ICS Chartr EP 200

Distribution

Distributed in 48 states:

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