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
- Recall Number
- Z-2175-2025
- Event Number
- 97197
- Firm
- Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom
- FEI Number
- 3003832357
- Product Code
- MHX
- Status
- Open, Classified
- Root Cause
- Software change control
- Initiated
- May 30, 2025
- Posted
- July 25, 2025
Description
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
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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Philips mailed field safety notices to customers and distributors who were informed of the following: Reverting to the outdated software version reintroduces the video laryngoscope issue previously corrected in FSN-2023-CC-EC-005 (Unexpected Device Error When Used with Tempus Pro Video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 [email protected] 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 [email protected]
Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
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