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Philips hemodynamic application
Official notice
16 May 2024
Last checked
16 May 2024
An official Health Canada notice concerns Philips hemodynamic application. 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 Published 2024-05-16.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75526
Official notice
2024-05-16
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Philips.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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