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 Philips Tempus Pro Patient Monitor is designed for monitoring vital signs, including intracranial pressure and bladder pressure in medical settings. Healthcare providers use it to make critical decisions for patient care.
The monitor's measurements for ICP and BDR have not been tested for accuracy. This lack of validation poses a risk of incorrect clinical decisions if healthcare providers rely on these readings.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers relying on the monitor for patient assessments. The urgency for action is high as incorrect measurements can lead to serious health implications.
Model numbers and serial numbers are typically found on the back or bottom of the monitor, as well as in the user manual.
Expect a timeline of 4-6 weeks for processing refunds or replacements after following the recall instructions.
Keep copies of all correspondence regarding the recall, including receipts, emails, and any notifications from the manufacturer.
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.
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