Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive...

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases on 2024-05-02. FDA classified it as Class II and gives the reason as "Potential for pressure wave data synchronization from two devices may not be correct". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.