🔍 RecallPedia

The ICS CHARTR EP 200

Class I - Dangerous
🏥 Medical Devices Recalled: May 28, 2019 GN Otometrics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GN Otometrics
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

The ICS CHARTR EP 200

Product Codes/Lot Numbers:

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

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0170-2020

Related Recalls

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

GN Otometrics

Class I - Dangerous

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

Aug 1, 2019 Diagnostic Equipment Nationwide View Details →