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)]
- Recall Initiated
- April 16, 2025
- Posted
- April 24, 2025
- Recall Number
- Z-1666-2025
- Quantity
- 6,961 units
Reason for Recall
software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
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, FI, FR, GB, HK, IE, IL, IS, IT, KY, MY, NL, NO, OM, PL, PT, RO, SA, SE, SG, SI, SL, TH, ZA.
Lot / Code Info
All Lots/ UDI-DI(s): 00-1004-R - 05060472440020 & 05060472442901; 00-1007-R - 05060472440013 & 05060472442918; 00-1024-R - 05060472441027 & 05060472442925; 00-1026-R - 05060472441058 & 05060472442932; 00-1004 - 05060472440624; 00-1007 - 05060472440655
Root Cause
Device Design
Action Taken
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 letter with or near your Tempus Pro Monitor. 4. Complete and return the Urgent Field Safety Notification Response Form included with this letter within 30 days of receipt of this notice. 5. This notice must be shared with all relevant personnel within your organization and with any organization where the potentially affected devices have been transferred.