Inseego dongle kit flash drives carry outdated patient monitor software
Inseego USB8 4G Dongle Kits for the Tempus Pro Monitor are being recalled because the kit's USB flash drive contains outdated software that could revert the monitor and reintroduce a previous issue. 55 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: outdated software could reintroduce a previously recalled monitor fault, which the notice links to delayed treatment and hypoxia, with none reported.
Plain-English summary
The Inseego USB8 4G Dongle Kit, part number 01-2298, containing a USB flash drive, part number 43-2011, an accessory to the Tempus Pro Monitor (REF 00-1007-R, 00-1024-R and 00-1026-R), is being recalled. The action covers 55 units.
According to the manufacturer, the kit USB flash drive contains outdated software, which could result in reverting the patient monitor to outdated software and reintroducing the video laryngoscope issue related to an August 2023 recall. The notice states this could lead to delay in diagnosis, delayed treatment and hypoxia due to unexpected loss of video laryngoscopy and other monitoring. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including in South Carolina, Kentucky, Nevada, Iowa and Michigan in the United States.
Facilities should identify affected stock using the part numbers, REF and UDI-DI codes above and follow the instructions issued by the manufacturer.
The recalled product
- 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
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Affected units
- 55
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- REF/UDI-DI: 00-1007-R/05060472440013
- 05060472442918
- 00-1024-R/05060472441027
- 05060472442925
- 00-1026-R/05060472441058
- 05060472442932. Software Version: vx.28
Distribution
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