The ICS CHARTR EP 200
FDA Device Recall #Z-0170-2020 — Class II — May 28, 2019
Recall Summary
| Recall Number | Z-0170-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 28, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GN Otometrics |
| Location | Taastrup |
| Product Type | Devices |
| Quantity | 3071 individual units |
Product Description
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.
Distribution Pattern
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 Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guyana, Hong Kong, Hungary, India, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Malaysia, Maldives, Mayotte, Mexico, Morocco, Morocco, Netherlands, 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
Lot / Code Information
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
Other Recalls from GN Otometrics
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2553-2019 | Class II | Gold Cup Leadwire and Snap Leadwire with the fo... | Aug 1, 2019 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.