Remote Diagnostic Technologies recalls Tempus LS defibrillators with specific software and serial numbers due to not being approved for US distribution. Affected units may pose safety risks.
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Remote Diagnostic Technologies is recalling Tempus LS defibrillators with specific software versions and serial numbers because they were not approved for sale in the US market. This recall is important because unapproved medical devices could pose safety risks to users.
Defibrillators not approved for the US market may not meet safety and performance standards required by the FDA. This could lead to improper function during critical medical emergencies, potentially causing harm to patients.
Users of Tempus LS defibrillators with the specific software version 1.3.5 and serial numbers 7021.002073 or 7021.002074 are affected. Healthcare providers and emergency responders using these devices are at the highest risk.
Check for the software version 1.3.5 and serial numbers 7021.002073 or 7021.002074 on your Tempus LS defibrillator. The device may also have the UDI code (01)07613365001693.
Verify the software version and serial numbers on your Tempus LS defibrillator to confirm if it is affected.
The Tempus LS defibrillators with software version 1.3.5 and specific serial numbers were not approved for distribution in the US market by the FDA.
Check for software version 1.3.5 and serial numbers 7021.002073 or 7021.002074 on your device. The UDI code (01)07613365001693 may also be present.
The recall record does not specify a remedy, so contact the manufacturer directly for guidance.
We’ve drafted a message you can send Remote Diagnostic Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-0861-2022 — Remote Diagnostic Technologies Remote Diagnostic Technologies Hello, I own a Remote Diagnostic Technologies that is covered by recall Z-0861-2022 from Remote Diagnostic Technologies. 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.
