Recall – Cardio Physiomonitoring System Software Issues

Company: Philips Electronics North America Corporation
Date of Enforcement Report: 12/14/2018
Class II


Xper Flex Cardio Physiomonitoring System, Software versions and, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081

Recall Number: Z-0614-2019


There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update


Philips Electronics North America Corporation, Andover, MA on 11/15/2018. Voluntary: Firm Initiated, recall is ongoing.

651 units

U.S. Nationwide and International

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
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