Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring
Service numbers associated with FC2010:
Xper Flex Cardio 2010 Rev A 453564241901
Xper Flex Cardio 2010 Rev B 453564483321
Flex Cardio FC2010 Rev C 453564621791
Xper Flex Cardio 2010 REV C RUEXCHANGE 453564675021
Xper Flex Cardio 2010 Rev D 453564669081
Xper Flex Cardio 2010 Rev D Russia 453564674581
Xper Flex Cardio FC2010 Rev E 453564845841
Xper Flex Cardio 2010 Rev E Russia 453564845881
Service numbers associated with FC2020:
Xper Flex Cardio 2020 Rev A 453564241911
Xper Flex Cardio 2020 Rev B 453564483331
Flex Cardio FC2020 Rev C 453564621801
Xper Flex Cardio 2020 Rev D 453564675001
Xper Flex Cardio FC2020 Rev E 453564845861
Software version number: 1.5.19 and 1.6.8
Recall Date: Mar 29, 2021
Mfg:
Philips North America Llc
Mfg Country:
United States
Recall ID: 87732
Product ID: 186883
Enforcement Date: May 5, 2021
Last Published: Apr 29, 2021
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Emert Number: Z-1517-2021
Emert Status: Notified