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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Remote Diagnostic Technologies Ltd.: Philips Tempus LS-Manual Defibrillator Recalled for Signal Interference Risk

Agency Publication Date: June 6, 2024
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Summary

Remote Diagnostic Technologies is recalling 1,745 Philips Tempus LS-Manual Defibrillators because using them at the same time as other heart monitoring devices can cause electrical noise or interference. This interference can distort the electrocardiogram (ECG) signal, which may prevent the device from providing the necessary life-saving heart pacing or defibrillation pulse. This recall affects devices with part number 00-3020 and serial numbers below 7022.002871 that are being used with specific operator manuals.

Risk

Electrical noise from multiple devices can mask a patient's true heart rhythm, leading the defibrillator to either fail to deliver a shock when needed or deliver an inappropriate shock. This could result in ineffective treatment during a cardiac emergency, potentially leading to serious injury or death.

What You Should Do

  1. Check your device for Part Number 00-3020 and UDI-DI 07613365002737 to see if it is affected.
  2. Verify the serial number on your device; this recall applies to all Serial Numbers prior to 7022.002871.
  3. Identify your User/Operator Manual version; the recall applies to version 41-3007EN-01 and all versions prior to it.
  4. Contact your healthcare provider or Remote Diagnostic Technologies Ltd. immediately for specific instructions on how to safely use the device or to receive updated guidance.
  5. Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program online or by phone.
  6. Contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions about this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Philips Tempus LS-Manual Defibrillator
Model / REF:
00-3020
UDI-DI-07613365002737
Lot Numbers:
Serial Numbers prior to 7022.002871
User/Operator Manual Versions: 41-3007EN-01 and prior

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94618
Status: Active
Manufacturer: Remote Diagnostic Technologies Ltd.
Sold By: Authorized medical distributors
Manufactured In: United Kingdom
Units Affected: 1745
Distributed To: Virginia, District of Columbia, Massachusetts, Wyoming, Arizona, Florida, California, New Mexico, New Jersey, Tennessee, Ohio, Kansas, Indiana, New York, Illinois, Texas, Nevada, Nebraska, Pennsylvania, Alabama, Iowa, Georgia, Missouri, Kentucky, Wisconsin, Oregon, Colorado, West Virginia, Washington, Utah, Idaho, Oklahoma, Minnesota, Maine, Montana, Michigan, North Carolina, North Dakota, Maryland, Delaware, Vermont

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.