Recall Z-1729-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
| Date | May 7, 2025 (initiated Apr 15, 2025) |
| Status | Open, Classified |
| Reason | Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements. |
| Root cause | Software design |
| Action | On 4/15/2025, correction notices were mailed to customers and distributors informing them of the following: I) The User/Operator Manual provides precautions and warnings on maintaining appropriate power or battery supply, which may reduce the risk of occurrence of an "MPM Application" software error message: -Warning (In Chapter 2, Getting started): Ensure the latches on both sides of the battery are fully engaged prior to using the Tempus - an incorrectly fitted battery could result in the tempus losing power during use. -Note: Before removing the battery, you must switch off the Tempus Pro |
| Quantity | 6961 |
| Distribution | Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, , MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE, DC and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, |
| 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 |