Tempus LS Defibrillator Software Error: Delay in Therapy Risk
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63904-tempus-ls-defibrillator-software-error-delay-in-therapy-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63904-tempus-ls-defibrillator-software-error-delay-in-therapy-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0564-2021
Cite this page
“Tempus LS Defibrillator Software Error: Delay in Therapy Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63904-tempus-ls-defibrillator-software-error-delay-in-therapy-risk. Based on FDA recall #Z-0564-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0564-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Remote Diagnostic Technologies- Category
Medical device
What to do — step by step
Check Software Version
Verify your Tempus LS defibrillator's software version; affected units have version 1.3.4.
Contact Manufacturer
Reach out to Remote Diagnostic Technologies for guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0564-2021 (November 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0564-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.