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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/Monitoring Devices

Philips Tempus Pro Patient Monitors Recalled for Software Freezes

Agency Publication Date: May 7, 2025
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Summary

Remote Diagnostic Technologies Ltd. is recalling approximately 6,961 Philips Tempus Pro Patient Monitors because software issues can cause the devices to freeze or reboot unexpectedly. The recall affects models 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007 running software versions prior to vx.40. These critical failures can occur during device startup, while performing an ECG, or when connecting the monitor to a Smart Mount, which may lead to delays in monitoring and treatment.

Risk

The software defects can cause the monitor to become unresponsive or restart during patient care, potentially resulting in a loss of vital sign monitoring or a delay in emergency medical intervention. Additionally, certain older software versions may generate inaccurate heart rhythm interpretations, which could lead to incorrect diagnosis or treatment decisions.

What You Should Do

  1. This recall involves Philips Tempus Pro Patient Monitors with software versions prior to vx.40, specifically models 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007.
  2. Identify your device by checking the REF and software version printed on the device label or packaging; see the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Remote Diagnostic Technologies Ltd. or your distributor to arrange return, replacement, or a software correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information about this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Philips Tempus Pro Patient Monitor
Variants: Software versions prior to vx.40
Model / REF:
00-1004-R
00-1007-R
00-1024-R
00-1026-R
00-1004
00-1007
UDI:
05060472440020
05060472442901
05060472440013
05060472442918
05060472441027
05060472442925
05060472441058
05060472442932
05060472440624
05060472440655

Software update vx.40 is intended to address MPM Application errors, 12-lead ECG freezes, Smart Mount reboots, and inaccurate rhythm/morphology statements.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96719
Status: Active
Manufacturer: Remote Diagnostic Technologies Ltd.
Sold By: Authorized Medical Device Distributors
Manufactured In: United Kingdom
Units Affected: 6961
Distributed To: Arizona, Virginia, Florida, California, Texas, New Mexico, Iowa, New Jersey, Tennessee, Ohio, Kansas, Indiana, North Carolina, Illinois, Wyoming, Wisconsin, Nevada, New York, Nebraska, Pennsylvania, Alabama, Massachusetts, Georgia, Missouri, Colorado, Oklahoma, Kentucky, Oregon, Mississippi, Michigan, Hawaii, Washington, Utah, West Virginia, Idaho, North Dakota, New Hampshire, Minnesota, Montana, Maine, Maryland, Delaware, District of Columbia

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.