Lower risk Medical device recall · FDA · Published October 28, 2024

Tempus LS Defibrillator Model 00-3020 Recall: Incorrect Labels May Cause Misidentification

Remote Diagnostic Technologies recalls Tempus LS-Manual Defibrillator Model 00-3020 due to incorrect labels during servicing. Labels have wrong product names and CAT numbers, potentially causing misidentification. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0557-2025Medical device Remote Diagnostic Technologies ›

Lower-risk recall

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

Take action

Contact the company

Recalling firmRemote Diagnostic Technologies Ltd.Farnborough Aerospace Centre, Aerospace Boulevard · Farnborough, United Kingdom

✎ GovInfoNow plain-language explainer

Remote Diagnostic Technologies is recalling Tempus LS-Manual Defibrillators with model number 00-3020 because labels during servicing contain incorrect product names and CAT numbers. This could lead to misidentification of the device, which might cause confusion in medical settings. Read more at govinfonow.com/recall/53635-tempus-ls-defibrillator-model-00-3020-recall-incorrect-labels-may.

Source Summary by GovInfoNow · govinfonow.com/recall/53635-tempus-ls-defibrillator-model-00-3020-recall-incorrect-labels-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0557-2025

Cite this page

“Tempus LS Defibrillator Model 00-3020 Recall: Incorrect Labels May Cause Misidentification.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53635-tempus-ls-defibrillator-model-00-3020-recall-incorrect-labels-may. Based on FDA recall #Z-0557-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0557-2025%22&limit=1).

The FDA announced on Oct. 28, 2024, that Remote Diagnostic Technologies Ltd. is recalling the Tempus LS-Manual Defibrillator Model 00-3020 due to incorrect labels applied during servicing. The hazard involves labels containing the wrong product name and CAT number.

How to tell if you have it

Brand: Remote Diagnostic Technologies
Product: Tempus LS-Manual Defibrillator
Model Number: 00-3020
UDI-DI code: 07613365002737
Serial Numbers: 7022.000367, 7022.000387, 7022.000392, 7022.000462, 7022.000463, 7022.000464, 7022.000559, 7022.000591, 7022.000595, 7022.000711, 7022.000781, 7022.000786, 7022.00108, 7022.001175, 7022.001201, 7022.00129, 7022.001556, 7022.001582

The hazard

The devices have incorrect labels applied during servicing that contain the wrong product name and CAT number.

Context

GovInfoNow's records show Remote Diagnostic Technologies Ltd. has had 11 other recalls on record since Nov. 17, 2020. Other recent recalls of similar products include Medline TRACH TUBE KIT Recall: Labeling Discrepancy Hazard (July 10, 2026), Omnicell i.v.Station Label Stock Recall: Risk of Mislabeled Syringes (March 25, 2026), and Philips Cardiac Workstation 7000: Inaccurate Heart Rate Data Risk (July 1, 2026).

How to tell if you have this one

Check for the model number 00-3020 on the device. Look for specific serial numbers listed: 7022.000367, 7022.000387, 7022.000392, 7022.000462, 7022.000463, 7022.000464, 7022.000559, 7022.000591, 7022.000595, 7022.000711, 7022.000781, 7022.000786, 7022.00108, 7022.001175, 7022.001201, 7022.00129, 7022.001556, 7022.001582.

Brand
Remote Diagnostic Technologies
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Labels
Look for incorrect product names or CAT numbers on the device labels.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 8 states.

FDA distribution: “U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Florida, Missouri, New York, Ohio, Texas, Virginia.

Recall timeline

FDA published this recall 37 days after the firm started it.

Oct 28, 2024Firm started the recall
Nov 26, 2024FDA classified it Class III
Dec 4, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53635-tempus-ls-defibrillator-model-00-3020-recall-incorrect-labels-may">Tempus LS Defibrillator Model 00-3020 Recall: Incorrect Labels May Cause Misidentification (GovInfoNow)</a>

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-0557-2025 (October 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0557-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.