BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-1027-2026 · Initiated November 26, 2025

    Recall

    Recall Number
    Z-1027-2026
    Event Number
    97889
    Firm
    Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom
    FEI Number
    3003832357
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 26, 2025
    Posted
    January 8, 2026

    Description

    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

    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.

    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 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 [email protected] For further information about this issue contact the firm at (800) 722-9377 or [email protected]

    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.

    Quantity

    7129