Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an ac
Summary
The FDA issued a Class II for Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive by Remote Diagnostic Technologies Ltd.. Reason: Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryn.
Details
Source
Device Recall
External ID
Z-2175-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
Lot/Code Info: REF/UDI-DI: 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932. Software Version: vx.28
Quantity Affected: 55
Reason for Recall
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Distribution
Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-30
Company
Farnborough
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remote Diagnostic Technologies Ltd. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Remote Diagnostic Technologies Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remote Diagnostic Technologies Ltd. have FDA actions?
Remote Diagnostic Technologies Ltd. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2175-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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