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

FDA device recall Z-1926-2024 · posted 2024-05-30 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

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

Action taken

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.

Root cause

Component design/selection

Status

Open, Classified

Product code

MWI

Quantity affected

391 units

Distribution

Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic,

Date initiated

2024-05-02

Date posted

2024-05-30

Location

Best, Netherlands

Related 510(k) clearances