Recall Z-1666-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Remote Diagnostic Technologies Ltd.
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
| Date | Apr 24, 2025 (initiated Apr 16, 2025) |
| Status | Open, Classified |
| Reason | software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope. |
| Root cause | Device Design |
| Action | On April 16, 2025, Remote Diagnostic Technologies Ltd (subsidiary of Philips) issued a Urgent Medical Device Correction to affected consignees via mail. Philips ask consignees to take the following: 1. DO NOT connect the Video Laryngoscope USB probe to the Tempus Pro during device boot-up. Once Patient Details dialog appears, enter patient data, then plug in the Video Laryngoscope USB probe. 2. If the Tempus Pro Monitor displays the error dialog screen (where the user is asked to restart the device), press the Shutdown Button and restart the Tempus Pro Monitor. 3. Keep a copy of this let |
| Quantity | 6,961 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES |
| FDA record | Open on fda.gov |