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Lower risk Medical device recall · FDA · Published May 30, 2025

Inseego USB8 4G Dongle Kit Recall: Outdated Software May Cause Diagnosis Delays

Inseego recalls USB8 4G Dongle Kit with outdated software that could cause video laryngoscope issues, delaying diagnosis and treatment. Affected units include Tempus Pro Monitor accessories with specific part numbers.

🇺🇸 FDA recall #Z-2175-2025Medical deviceInseego ›
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Contact the company

Recalling firmRemote Diagnostic Technologies Ltd.Farnborough Aerospace Centre, Aerospace Boulevard · Farnborough, United Kingdom
✎ GovInfoNow plain-language explainer

Inseego is recalling USB8 4G Dongle Kits that contain outdated software. This could cause the patient monitor to revert to older software, potentially delaying diagnosis and treatment due to loss of video laryngoscopy. Read more at govinfonow.com/recall/52174-inseego-usb8-4g-dongle-kit-recall-outdated-software-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/52174-inseego-usb8-4g-dongle-kit-recall-outdated-software-may-cause · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2175-2025

Cite this page

“Inseego USB8 4G Dongle Kit Recall: Outdated Software May Cause Diagnosis Delays.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52174-inseego-usb8-4g-dongle-kit-recall-outdated-software-may-cause. Based on FDA recall #Z-2175-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2175-2025%22&limit=1).

Remote Diagnostic Technologies Ltd. recalled the Inseego USB8 4G Dongle Kit on May 30, 2025, according to the FDA. The kit contains a USB flash drive with outdated software that could revert patient monitors to an older version, potentially causing hypoxia or delayed diagnosis.

How to tell if you have it

  • Brand: Inseego
  • Product: Inseego USB8 4G Dongle Kit, Part Number: 01-2298
  • Contains: USB Flash Drive, Part Number: 43-2011
  • Compatible Monitors: Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
  • Software Version: vx.28
  • Units Affected: 55

The hazard

The kit's USB flash drive contains outdated software, which could result in reverting the patient monitor to outdated software and reintroducing a video laryngoscope issue. This could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy, and loss of all other monitor measurements during system restart.

Context

GovInfoNow's records show Remote Diagnostic Technologies Ltd. has issued 11 other recalls since November 17, 2020. Recent recalls include a November 26, 2025, recall for patient monitors with unvalidated Intracranial Pressure measurements and April 16, 2025, and April 15, 2025, recalls for Tempus Pro Patient Monitor software errors. Other recent recalls of similar products include a July 31, 2026, recall for Philips PIC iX Essentials Software Freezes, a June 5, 2026, recall for Philips Telemetry Monitor 5500 connection failure risks, and an August 21, 2026, recall for Philips Achieva 3.0T MRI software issues.

How to tell if you have this one

Check if your Tempus Pro Monitor has the USB8 4G Dongle Kit with part number 01-2298. The kit includes a USB flash drive with part number 43-2011 and software version vx.28.

  • Brand
    Inseego
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Identify if your Tempus Pro Monitor has the USB8 4G Dongle Kit with part number 01-2298 and the USB flash drive with part number 43-2011.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 5 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Iowa, Kentucky, Michigan, Nevada, South Carolina.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: May 30, 202512. FDA classified it Class II: Jul 25, 202523. Published in FDA’s Enforcement Report: Aug 6, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2175-2025 (May 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2175-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA