Remote Diagnostic Technologies Ltd. recalls Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an a…

Recall date

May 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2175-2025

FDA classification

Class II

Brand / firm

Remote Diagnostic Technologies Ltd.

Sold / distributed

Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.

Why it was recalled

Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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