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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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High RiskFDA Device
Medical Devices/Monitoring Devices

Remote Diagnostic Technologies Ltd.: Tempus Pro Patient Monitors Recalled for Screen Error and Restart Risks

Agency Publication Date: September 21, 2023
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Summary

Remote Diagnostic Technologies Ltd. is recalling 3,524 Philips Tempus Pro Patient Monitors (models 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007) when used with the Tempus Pro Video Laryngoscope. A software and hardware defect can cause a full-screen error message requiring a 60-100 second system restart, often occurring when the laryngoscope is unplugged. During this time, medical professionals cannot view vital signs or see the patient's airway, which can lead to critical delays in treatment or dangerous drops in oxygen levels.

Risk

The device may stop functioning and require a lengthy restart, preventing the visualization of the patient's airway during intubation and the monitoring of vital signs, potentially leading to hypoxia or treatment delay.

What You Should Do

  1. Identify if your device is affected by checking the model number (REF) on the back of the monitor for: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, or 00-1007.
  2. Verify the hardware and software version: this recall affects monitors with hardware version Trizeps-7 and software versions v07.26 through v07.30.
  3. Confirm if the monitor is used with a Tempus Pro Video Laryngoscope (REF 01-2044).
  4. Check the UDI-DI codes on your device label: 05060472440020, 05060472442901, 05060472440013, 05060472442918, 05060472441027, 05060472442925, 05060472441058, 05060472442932, 05060472440624, or 05060472440655.
  5. Contact your healthcare provider or Remote Diagnostic Technologies Ltd. immediately for further instructions and information on necessary software or hardware updates.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instructions

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

Affected Products

Product: Philips Tempus Pro Patient Monitor (REF: 00-1004-R)
Model / REF:
00-1004-R
Lot Numbers:
Hardware version: Trizeps-7
Software versions v07.26 through v07.30
UDI-DI: 05060472440020
UDI-DI: 05060472442901
Product: Philips Tempus Pro Patient Monitor (REF: 00-1007-R)
Model / REF:
00-1007-R
Lot Numbers:
Hardware version: Trizeps-7
Software versions v07.26 through v07.30
UDI-DI: 05060472440013
UDI-DI: 05060472442918
Product: Philips Tempus Pro Patient Monitor (REF: 00-1024-R)
Model / REF:
00-1024-R
Lot Numbers:
Hardware version: Trizeps-7
Software versions v07.26 through v07.30
UDI-DI: 05060472441027
UDI-DI: 05060472442925
Product: Philips Tempus Pro Patient Monitor (REF: 00-1026-R)
Model / REF:
00-1026-R
Lot Numbers:
Hardware version: Trizeps-7
Software versions v07.26 through v07.30
UDI-DI: 05060472441058
UDI-DI: 05060472442932
Product: Philips Tempus Pro Patient Monitor (REF: 00-1004)
Model / REF:
00-1004
Lot Numbers:
Hardware version: Trizeps-7
Software versions v07.26 through v07.30
UDI-DI: 05060472440624
Product: Philips Tempus Pro Patient Monitor (REF: 00-1007)
Model / REF:
00-1007
Lot Numbers:
Hardware version: Trizeps-7
Software versions v07.26 through v07.30
UDI-DI: 05060472440655

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92914
Status: Active
Manufacturer: Remote Diagnostic Technologies Ltd.
Sold By: Authorized Medical Distributors
Manufactured In: United Kingdom
Units Affected: 3,524
Distributed To: Arizona, Alabama, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming
Agency Last Updated: April 11, 2024

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.