Philips recalled 7,129 Tempus Pro Patient Monitors on November 26, 2025. The monitors may provide unvalidated measurements for Intracranial Pressure and Bladder Pressure. Incorrect readings could lead to critical clinical decisions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Remote Diagnostic Technologies Ltd. or your healthcare provider for instructions. Notification method: Letter
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The recalled models include REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, and USB 2-Channel IBP Module REF: 01-2017. These devices were distributed worldwide, including states like AZ, CA, TX, and FL.
The Tempus Pro Patient Monitor may provide unvalidated measurements for Intracranial Pressure (ICP) and Bladder Pressure (BDR). Healthcare providers may make incorrect clinical decisions based on these inaccurate readings.
There have been no reported injuries or deaths directly linked to the inaccurate readings of these monitors. However, the potential for incorrect clinical decisions raises significant safety concerns.
Stop using the Philips Tempus Pro Patient Monitor immediately. Follow the recall instructions provided by Philips or your healthcare provider. Contact Remote Diagnostic Technologies Ltd. for further instructions.
For more information, contact Remote Diagnostic Technologies Ltd. at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1027-2026.
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