The ICS CHARTR EP 200 — Class II medical device recall Z-0170-2020
Terminated recall by GN Otometrics, reported 2019-10-30, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces whi
| Recall number | Z-0170-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GN Otometrics, Taastrup, Denmark |
| Recall initiated | 2019-05-28 |
| Classified | 2019-10-23 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2021-04-09 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, GY, HK, HR, HU, IE, IL, IN, IQ, IR, IT, JO, KR, KW, LB, LK, LU, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, QA, RO, RS, RU, SA, SE, SG, SV, TH, TR, TW, VN, ZA |
| Quantity | 3,071 individual |
| UPC / GTIN / UDI-DI | 05713315002700, 05713315002717, 05713315002724, 05713315003226, 05713315006173, 05713315006326, 05713315006333, 05713315006340, 05713315006357, 05713315006364, 05713315006371, 05713315006388, 05713315006395, 05713315006401, 05713315006418, 05713315006425, 05713315006432, 05713315006449, 05713315007996 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0170-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.