Recall Z-1027-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
| Date | Jan 8, 2026 (initiated Nov 26, 2025) |
| Status | Open, Classified |
| Reason | Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions. |
| Root cause | Device Design |
| Action | Correction notices were mailed on 11/26/2025 to customers were informed of the following: U.S.: Do not use the Intracranial Pressure or Bladder Pressure measurements. Firm intends to update labeling. OUS: Continue to use the Intracranial Pressure and Bladder Pressure measurements. Firm intends to conduct verification and validation testing. Firm recommends routine cross-verification of most ICP/BDR readings serves to reduce potential risk inherent with ICP/BDR use. Share the correction notice with all relevant personnel within your organization and with any organization where affected devi |
| Quantity | 7129 |
| 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 and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG |
| 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 |