Recall of Tempus LS manual defibrillators with software version 1.3.4 due to potential delay in therapy when switching between pacer and manual modes. Affected units have specific serial numbers.
A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.
Remote Diagnostic Technologies recalls certain Tempus LS manual defibrillators with software version 1.3.4. This software error may cause delays in therapy when switching from pacer mode back to manual mode, potentially preventing clinicians from seeing ECG waveforms needed for shock decisions.
The software error causes the ECG calibration to go out of alignment when switching from pacer mode back to manual mode. This may delay therapy by preventing clinicians from seeing ECG waveforms needed to determine if a shock is required, though the device can still deliver manual shocks.
Healthcare professionals using the Tempus LS defibrillator in pre-hospital care or transport settings are most at risk. The affected units have specific serial numbers listed in the recall.
Check if your Tempus LS defibrillator has software version 1.3.4. Affected units have specific serial numbers listed in the recall, including LS 7022.000218 and other numbers starting with LS 7022.
Verify your Tempus LS defibrillator's software version; affected units have version 1.3.4.
Reach out to Remote Diagnostic Technologies for guidance on next steps.
No, only specific units with software version 1.3.4 and the listed serial numbers are affected.
Yes, the device can still deliver manual defibrillation shocks despite the software error.
Check if your Tempus LS has software version 1.3.4 and a serial number from the list provided in the recall.
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-0564-2021 — Remote Diagnostic Technologies Remote Diagnostic Technologies Hello, I own a Remote Diagnostic Technologies that is covered by recall Z-0564-2021 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.
