CardioTek recalls EP-TRACER Software V2.x versions with specific serial numbers due to inadequate electrical insulation. This could pose a risk of electric shock. Affected users should contact CardioTek for details.
Device did not pass electrical safety testing for adequate insulation.
CardioTek is recalling software versions EP-TRACER V2.x that failed electrical safety testing. This could lead to electric shock if the software is used improperly. Affected users should stop using the software immediately and contact CardioTek for instructions.
The software did not pass electrical safety testing, meaning it may have inadequate insulation. This could allow electric current to flow through the device, potentially causing electric shock if the software is used with medical equipment.
Users of CardioTek EP-TRACER Software V2.x with the listed serial numbers are affected. Medical professionals using this software for patient monitoring are at higher risk due to potential electric shock.
Check your software version and serial numbers against the list provided. The affected versions include EP-TRACER 38 and 102 with specific serial numbers from 2019 to 2022.
Identify your software version and serial numbers to confirm if they are in the recall list.
Reach out to CardioTek for instructions on how to stop using the software or get a replacement.
The software did not pass electrical safety testing, which could lead to electric shock if used improperly. However, the exact risk level is not specified in the recall notice.
Check your software version and serial numbers against the list provided in the recall notice. Affected versions include EP-TRACER 38 and 102 with specific serial numbers from 2019 to 2022.
Contact CardioTek directly for instructions on how to stop using the software or get a replacement. The recall notice does not specify a deadline for action.
We’ve drafted a message you can send CardioTek to request your refund or repair — edit it as you like.
Subject: Recall Z-1283-2022 — CardioTek CardioTek Hello, I own a CardioTek that is covered by recall Z-1283-2022 from CardioTek. 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.
