USB Monitor Kit Recalled for Outdated Software Causing Device Malfunction
The Inseego USB8 4G Dongle Kit is being recalled because its USB flash drive contains outdated software that could revert the Tempus Pro Monitor to a previous unsafe state, potentially causing loss of critical monitoring functions and delayed treatment.
What this means for you
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: This is an FDA Class II medical device recall for a patient monitor accessory. While no injuries or hospitalizations have been reported, the recall addresses a risk of reintroducing a critical monitoring malfunction that could lead to delayed diagnosis and hypoxia. The hazard is theoretical but involves loss of essential patient monitoring functions.
Plain-English summary
Remote Diagnostic Technologies Ltd. is recalling the Inseego USB8 4G Dongle Kit (Part Number 01-2298), which contains a USB Flash Drive (Part Number 43-2011). This kit is an accessory to the Tempus Pro Monitor. Approximately 55 units have been distributed worldwide, with US distribution in South Carolina, Kentucky, Nevada, Iowa, Michigan, and Great Britain.
The USB flash drive contains outdated software (Software Version vx.28). When used with the Tempus Pro Monitor, this outdated software could cause the monitor to revert to an outdated configuration, reintroducing a video laryngoscope issue that was the subject of an August 2023 recall.
If the monitor reverts to the outdated software, users could experience unexpected loss of video laryngoscopy and other monitor measurements during system restart. This could result in delay in diagnosis and delayed treatment, as well as potential hypoxia due to the loss of video laryngoscopy.
Affected users should stop using this dongle kit immediately and contact Remote Diagnostic Technologies Ltd. for a corrected USB8 4G Dongle Kit.
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.
- Hazard
- video-laryngoscope-loss
- monitor-malfunction
- delayed-diagnosis
- hypoxia
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
Distributed nationwide across the United States.
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