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Philips Electronics North America Corporation recalls Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 4535
Recalled December 26, 2018 · FDA recall Z-0614-2019 · Philips Electronics North America
Hazard
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. · FDA Class II
Units
651 units
Sold at
worldwide
Description
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.
Product
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →