FDA Device recall Z-0170-2020
The ICS CHARTR EP 200
- FDA Device
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of The ICS CHARTR EP 200 by Gn Otometrics, citing there is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0170-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-28 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Gn Otometrics |
| 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, WV |
Product
The ICS CHARTR EP 200
Reason
There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
Identifiers
| code_info | Part No. Description UDI of the Device 8-04-12733 ICS Chartr EP 200…Part No. Description UDI of the Device 8-04-12733 ICS Chartr EP 200 2Ch, 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), VEMP Monitor Kit and ASSR 05713315006432; 8-04-12730 ICS Chartr EP 200 2ch, 230 VAC (50 Hz) Incl. Insert Earphone; TDH49 Earhone w cable, Bone Conduction Transducer (B71) and ASSR 05713315006425; 8-04-12729 ICS Chartr EP 200 2Ch, 230 VAC (50 Hz) Incl. Insert Earphone, Bone Conduction Transducer (B71) and VEMP Monitor Kit 05713315006388; 8-04-12727 ICS Chartr EP 200 2Ch, 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable and VEMP Monitor Kit |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0170-2020%22
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