GN Otometrics A/S ICS Chartr EP 200 Insert 2 Ch, US OnlyRecalls & reported problems
Natus Medical Denmark ApS · Class 2
All models of GN Otometrics A/S (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- May 28, 2019Class IITerminated
There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
Z-0170-2020 · Root cause: Device Design · Recall details · FDA record ↗
Other Stimulator, Auditory, Evoked Response devices
- GN Otometrics A/S ICS Chartr EP 200 Insert, Bone 2 Ch, US onlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
- GN Otometrics A/S ICS Chartr EP 200 Insert, Bone & TDH49 2Ch, US onlyNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 recall0 reports
- 1077 DPOAE/TEOAE PROBE 8-69-41100PATH medical GmbH · Stimulator, Auditory, Evoked Response1 recall0 reports
- AuDX PRO Device with touchscreen 100098-AUPPATH medical GmbH · Stimulator, Auditory, Evoked Response1 recall0 reports
- ALGO Newborn Hearing Screener ALGO 5Natus Medical Incorporated · Stimulator, Auditory, Evoked Response3 reports
- NIM-Eclipse® NCCPUMedtronic Xomed, Inc. · STIMULATOR, AUDITORY, EVOKED RESPONSE2 reports
- GN Otometrics A/S MADSEN AccuScreenNatus Medical Denmark ApS · Stimulator, Auditory, Evoked Response1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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