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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

Inseego USB8 4G Dongle Kits Recalled for Outdated Software Risks

Agency Publication Date: July 25, 2025
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Summary

Remote Diagnostic Technologies Ltd. is recalling 55 Inseego USB8 4G Dongle Kits (Part Number: 01-2298), which are used with Tempus Pro Monitors. The kits contain a USB flash drive (Part Number: 43-2011) with outdated software (version vx.28) that can cause the medical monitor to revert to an older software version. This software regression could reintroduce a previously fixed defect that causes the monitor's video laryngoscope and all other vital sign measurements to fail during a system restart. No injuries or incidents have been reported.

Risk

The outdated software can cause a sudden loss of vital patient monitoring and video laryngoscopy during critical medical procedures. This failure can lead to hypoxia (lack of oxygen), delayed diagnosis, and delayed treatment for the patient.

What You Should Do

  1. This recall affects Inseego USB8 4G Dongle Kits (Part Number: 01-2298) containing USB Flash Drives (Part Number: 43-2011) with software version vx.28, used as accessories for Tempus Pro Monitors (REF numbers 00-1007-R, 00-1024-R, and 00-1026-R).
  2. Stop using the recalled USB flash drive kits immediately to prevent the monitor from reverting to outdated software.
  3. Contact Remote Diagnostic Technologies Ltd. or your medical equipment distributor to arrange for a software correction, kit replacement, or return.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device safety.

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: Inseego USB8 4G Dongle Kit (accessory for Tempus Pro Monitor)
Variants: Software Version: vx.28
Model / REF:
01-2298
43-2011
00-1007-R
00-1024-R
00-1026-R
UDI:
05060472440013
05060472442918
05060472441027
05060472442925
05060472441058
05060472442932

The kit contains a USB Flash Drive (Part Number: 43-2011). Affected Tempus Pro Monitor REFs: 00-1007-R, 00-1024-R, 00-1026-R.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97197
Status: Active
Manufacturer: Remote Diagnostic Technologies Ltd.
Sold By: Medical equipment distributors
Manufactured In: United Kingdom
Units Affected: 55
Distributed To: South Carolina, Kentucky, Nevada, Iowa, Michigan

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.