GN Otometrics recalls ICS CHARTR EP 200 devices due to risk of electrical shock from undergrounded surfaces. Affected models include various versions with specific part numbers.
There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
GN Otometrics is recalling the ICS CHARTR EP 200 hearing devices because they may cause electrical shock if improperly connected. This poses a risk to healthcare professionals and patients using the device.
The device has a risk of electrical shock due to undergrounded electrical surfaces. This can happen if the device is not properly connected or if there is a fault in the electrical system.
Healthcare professionals and patients who use the ICS CHARTR EP 200 hearing devices are at risk. Those with the specific part numbers listed in the recall are most affected.
Check for the ICS CHARTR EP 200 model with part numbers listed in the recall, such as 8-04-12733 to 8-04-12700. The devices are sold for healthcare use and may include specific features like bone conduction transducers.
Look for the part numbers listed in the recall, such as 8-04-12733 to 8-04-12700, to confirm if your device is affected.
Reach out to GN Otometrics for further instructions on how to address the issue if your device is affected.
The affected models include the ICS CHARTR EP 200 with part numbers from 8-04-12700 to 8-04-12733, as listed in the recall notice.
The recall notice does not specify a fix; it only states that affected devices may need to be checked with the manufacturer.
Check the part number on your device. If it matches any of the numbers listed in the recall (e.g., 8-04-12733 to 8-04-12700), it is affected.
We’ve drafted a message you can send GN Otometrics to request your refund or repair — edit it as you like.
Subject: Recall Z-0170-2020 — GN Otometrics GN Otometrics Hello, I own a GN Otometrics that is covered by recall Z-0170-2020 from GN Otometrics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
