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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

Tempus Pro Patient Monitors Recalled for Software Error Screen Issue

Agency Publication Date: April 24, 2025
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Summary

Remote Diagnostic Technologies Ltd. is recalling 6,961 Tempus Pro Patient Monitors due to a software issue that causes the monitor to display an error screen. This problem occurs specifically when a video Laryngoscope is attached to the monitor, which is used to measure and display portable vital signs. The recall affects multiple models of the Tempus Pro, including versions with and without integrated printers or headset docks. To date, there have been no reports of incidents or injuries related to this defect.

Risk

The software error can cause the monitoring screen to fail while a video laryngoscope is in use, potentially leading to a loss of patient visualization and vital sign monitoring during critical medical procedures.

What You Should Do

  1. This recall affects Tempus Pro Patient Monitors with reference numbers (REF) 00-1004-R, 00-1007-R, 00-1007, 00-1024-R, 00-1026-R, and 00-1004.
  2. Identify if your device is affected by checking the reference (REF) number and the Unique Device Identifier (UDI-DI) printed on the monitor label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

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: Tempus Pro non-printer, IBP, without headset dock
Model / REF:
00-1004-R
UDI:
05060472440020
05060472442901
Product: Tempus Pro non-printer, IBP, with headset dock
Model / REF:
00-1007-R
UDI:
05060472440013
05060472442918
Product: Tempus Pro printer
Model / REF:
00-1024-R
UDI:
05060472441027
05060472442925
Product: Tempus Pro printer, IBP
Model / REF:
00-1026-R
UDI:
05060472441058
05060472442932
Product: Tempus Pro (IB Only)
Model / REF:
00-1004
UDI:
05060472440624
Product: Tempus Pro, BT Dock (IB Only)
Model / REF:
00-1007
UDI:
05060472440655

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96678
Status: Active
Manufacturer: Remote Diagnostic Technologies Ltd.
Manufactured In: United Kingdom
Units Affected: 6,961 units
Distributed To: Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming
Agency Last Updated: May 16, 2025

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.