Philips Medical Systems Nederland B.V. is recalling 391 units of its Interventional Hemodynamic Application (Software Versions 1.2.0 through 1.3.1). This software is used during invasive heart and blood vessel examinations to monitor and record critical pressure data. The recall was initiated because pressure wave data from two different devices may not synchronize correctly, which could lead to inaccurate medical readings during cardiac procedures. Patients or healthcare providers with these systems should contact the manufacturer or their healthcare facility immediately.
If the pressure wave data from connected devices does not align correctly, medical professionals may receive inaccurate hemodynamic readings. This synchronization failure could lead to incorrect diagnoses or improper treatment decisions during sensitive cardiac and vascular investigations.
Corrective software update or guidance
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.