Company: Remote Diagnostic Technologies Ltd.
Date of Enforcement Report: 7/25/2025
Class: II
PRODUCT
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
Recall Number:
Z-2175-2025
REASON:
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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.
RECALLING FIRM/MANUFACTURER:
Remote Diagnostic Technologies Ltd.
VOLUME:
55
DISTRIBUTION:
Worldwide – US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
