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Official recall record

Philips Hemodynamic Application

Health Canada — Medical Devices · 2024-05-16 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-05-16
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Philips has become aware of a potential issue with Philips Interventional Hemodynamic Application R1.2.X, R1.3.0 and R1.3.1, where synchronization of pressure wave data received from two devices, the Intellivue X3 and Functional Measurement Patient Interface Module (FM-PIM) may not be correct. There might be a delay of the FM-PIM data with respect to the Intellivue X3 data which is not constant in time. When this occurs, the calculation of measurements will be affected, specifically the IFR (Instantaneous Wave-Free Ratio) and FFR (Fractional Flow Reserve) values. Recall Start Date: May 3, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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