Recall Z-2175-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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: 00-1007-R, 00-1024-R, 00-1026-R
| Date | Jul 25, 2025 (initiated May 30, 2025) |
| Status | Open, Classified |
| Reason | Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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. |
| Root cause | Software change control |
| Action | 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Philips mailed field safety notices to customers and distributors who were informed of the following: Reverting to the outdated software version reintroduces the video laryngoscope issue previously corrected in FSN-2023-CC-EC-005 (Unexpected Device Error When Used with Tempus Pro Video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 respon |
| Quantity | 55 |
| Distribution | Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201746 | Tempus Pro Patient Monitor Remote Diagnostic Technologies Limited, Sep 18, 2020 |