Philips recalls Xper Flex Cardio Physiomonitoring System software versions 1.5.16.0322 and 1.6.1.0390 with model numbers 453564241901 and others. These versions may display inaccurate waveforms, frozen oxygen saturation readings, and blood pressure updates.
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 is recalling specific software versions of their Xper Flex Cardio Physiomonitoring System due to issues with waveform display accuracy, oxygen saturation readings freezing, and blood pressure updates failing in auto cycle mode. These problems could lead to incorrect medical monitoring readings.
The software issues can cause real-time waveforms to plot incorrectly, oxygen saturation (SpO2) values to freeze, and non-invasive blood pressure (NIBP) readings to stop updating when the device loses communication with the pump in auto cycle mode. This could lead to incorrect medical monitoring.
Healthcare professionals using the Xper Flex Cardio Physiomonitoring System with the specified software versions and model numbers are most at risk. Patients using this equipment may experience inaccurate monitoring readings.
Check if your device has software versions 1.5.16.0322 or 1.6.1.0390 and model numbers listed in the recall (e.g., 453564241901, 453564241911, etc.).
Verify your device's software version by checking the device settings or manual. If it matches the recalled versions (1.5.16.0322 or 1.6.1.0390), it is affected.
Contact Philips for updated software versions to fix the issues. The recall does not specify a deadline for updating.
Software versions 1.5.16.0322 and 1.6.1.0390.
Model numbers include 453564241901, 453564241911, 453564483321, and others listed in the recall.
Check your device's software version and model number against the list provided in the recall notice.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0614-2019 — Philips Philips Hello, I own a Philips that is covered by recall Z-0614-2019 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
