Remote Diagnostic Technologies Ltd. recalls Inseego USB8 4G Dongle Kit

Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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

On 5/30/3035, Philips mailed field safety notices to customers and distributors who were informed of the following: Reverting to the outdated software version reintroduces the video laryngoscope issue previously corrected in FSN-2023-CC-EC-005 (Unexpected Device Error When Used with Tempus Pro Video Laryngoscope). Customers were asked to do the following: 1) Dispose of USB Flash Drive. 2) Ensure monitor is on Software version vx.34 or higher. 4) If your device(s) is on a software version below vx.34, contact firm representative for software update instructions. 5) Complete and return response form via email to ECR.Recall.Response@Philips.com In addition, distributors were asked to do the following: 1) Modify the correction response form and substitute your firm's email and fax information. Send a copy of the correction notice and modified response form to each customer to whom you distribute the affected product. If you need any further information or support contact firm at (800) 722-9377 or email ECR.Recall.Response@Philips.com

• FDA enforcement recordOfficial FDA database entry for Z-2175-2025
• FDA 510(k) clearance · K201746The device's official FDA premarket clearance record
• FDA device classification · MHXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1025The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Remote Diagnostic Technologies Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.