Remote Diagnostic Technologies Ltd.: 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-

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Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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

Details from the source

Reason for recall: Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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. Quantity: 55 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

UPC codes

05060472440013, 05060472442918, 05060472441027, 05060472442925, 05060472441058, 05060472442932

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.