GN Otometrics recalls The ICS CHARTR EP 200

Hazard / Issue

There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.

Issued by

FDA

Affected States: 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV

Lot/Code Info: 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 05713315006418; 8-04-12725 ICS Chartr EP 200 2ch, 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable, Bone Conduction Transducer (B71), VEMP Monitor Kit, P300 and ASSR 05713315006395; 8-04-12723 ICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable 05713315006401; 8-04-12721 ICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone 05713315006371; 8-04-12720 ICS Chartr EP 200 2ch. 230 VAC (50 Hz) Incl. Insert Earphone, TDH49 Earhone w cable, Bone Conduction Transducer (B71) and EU power cord. 05713315007996; 8-04-12711 1073 ICS Chartr EP 200 w/o Vemp, CN only N/A; 8-04-12710 1073 ICS Chartr EP 200, CN only N/A; 8-04-12703 1073 ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US only 05713315002724; 8-04-12702 1073 ICS Chartr EP 200 Insert, Bone 2 Ch, US only 05713315002717; 8-04-12701 1073 ICS Chartr EP 200 ROW 2 Ch. N/A; 8-04-12700 1073 ICS Chartr EP 200 Insert 2 Ch, US Only 05713315002700; 8-04-12732 ICS Chartr EP 200 Limited, 1 ch, TDH49, 115/60 05713315006364; 8-04-12728 ICS Chartr EP 200 Limited, 1 ch Insert, Bone, TDH49 & VEMP Monitor Kit 05713315006333; 8-04-12726 ICS Chartr EP 200 Limited, 1 ch, TDH49 05713315006357; 8-04-12724 ICS Chartr EP 200 Limited, 1 ch Insert & TDH49 05713315006340; 8-04-12722 ICS Chartr EP 200 Limited, 1 ch, Insert 05713315006326; 8-04-12712 1073 Chartr EP 200 Limited, China N/A; and 8-04-12704 1073 Chartr EP 200 Limited 05713315003226