PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for pressure wave data synchronization from two devices may not be correct.

Recommended Action

Per FDA guidance

Consignees were mailed an URGENT Medical Device Correction notice, dated 4/30/24. Consignees are instructed to keep the provided notification with the documentation of affected systems until Philips implements the software correction, follow the provided instructions when connecting the pressure wire to the FM-PIM and refer to the FM Patient Interface Module (Option Manual, Chapters 3 and 5), and circulate the provided notification to all users of the system. In the case that steps described in the notification are not executed and/or the described issue is observed, perform the normalization procedure in accordance with Section 6.9 of the IFU for the Philips Hemodynamic Application. Consignees are to complete and return the provided response form within 30 days of receipt. Customers with any questions are to contact Philips Customer Care Solutions Center at 1-800-722-9377. Philips will install a software update to correct this issue and will contact consignees to schedule the onsite visit to perform the upgrade.