Recall Z-1027-2026
Remote Diagnostic Technologies Ltd. · initiated November 26, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: REF/UDI-DI: 00-1004/05060472440624; 00-1007/05060472440655; 00-1004-R/05060472440020, 05060472442901; 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932; User/Operator Manual Version 41-2001EN Serial Numbers: 30264 616174 616689 616695 616701 616703 616706 615658 615668 615551 615552 615555 615556 615557 615559 602803 602941 603335 603342 603406 603407 603409 603410 603412 602157 602159 602160 602163 602164 602168 602169 602170 602171 602172 615637 616688 614764 615435 615526 615604 615606 615607 615623 603631 604118 604119 604120 604127 604130 604138 616466 602877 602895 616584 616581 603518 603529 603555 614730 614734 614736 614737 614958 614970 614971 614972 614973 616719 616720 616725 616727 616978 616432 30100 30201 30202 30203 616491 616492 616493 616494 616496 616500 616503 616456 600613 615937 616338 616380 616678 616679 616683 616685 616687 616702 616344 616351 616384 616604 616608 616614 616682 616690 616691 616825 603857 603858 603859 603860 603862 603863 603865 603868 603869 603870 603871 603872 603876 603877 603881 603883 603885 603892 603897 603901 603906 603907 603908 603909 603914 603915…
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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 devices have been transferred. Distributors forward the notice to your customers. Store a copy of this notice with the User/Operator Manual. Complete and return the response form via email to ECR.Recall.Response@Philips.com For further information about this issue contact the firm at (800) 722-9377 or ECR.Recall.Response@Philips.com
Details
- Recall number
- Z-1027-2026
- Initiated
- November 26, 2025
- Posted by FDA
- January 8, 2026
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- 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, CA, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, KY, OM, CZ, SI, SL, GI, ZA, AF, SE, FI.
- Recalling firm
- Remote Diagnostic Technologies Ltd., Farnborough