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

FDA device recall Z-1027-2026 · posted 2026-01-08 · Open, Classified

Recall details

Recalling firm

Remote Diagnostic Technologies Ltd.

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.

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

Root cause

Device Design

Status

Open, Classified

Product code

MHX

Quantity affected

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

Date initiated

2025-11-26

Date posted

2026-01-08

Location

Farnborough, United Kingdom

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