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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

FDA Recall Z-1027-2026 · Posted 2026-01-08

Recalling FirmRemote Diagnostic Technologies Ltd.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2025-11-26
Product Quantity7129

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.

Firm 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]

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020-09-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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