Remote Diagnostic Technologies Ltd. is recalling approximately 7,129 Philips Tempus Pro Patient Monitors and USB 2-Channel IBP Modules. These monitors measure Intracranial Pressure (ICP) and Bladder Pressure (BDR), but these specific functions have not been tested or validated for accuracy. If healthcare providers use these unvalidated measurements to guide patient care, it could result in incorrect clinical decisions or inappropriate treatments. This recall affects various monitor models used worldwide, including in medical facilities across 41 U.S. states.
The use of unvalidated measurement data for intracranial or bladder pressure poses a risk of incorrect medical diagnosis and treatment. Inaccurate pressure readings could lead to serious medical errors in sensitive clinical environments where patient monitoring is critical.
Used with User/Operator Manual Version 41-2001EN.
Associated with Tempus Pro Patient Monitor recall.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.