Recall Z-1926-2024— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-1926-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-02

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2024-05-02. It names one FDA 510(k) clearance: K181311. Product: Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.. Reason: Potential for pressure wave data synchronization from two devices may not be correct..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2024-05-02
Firm location: Best, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K181311 — Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.·cleared 2018-09-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.