FDA-Device2025-08-06Class II
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
Remote Diagnostic Technologies Ltd.
Hazard
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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.
Sold states
Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
Affected count
55
Manufactured in
Farnborough Aerospace Centre, Aerospace Boulevard, Farnborough, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2175-2025Don't want to check this manually?
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