Recall Z-1517-2021 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Philips North America Llc
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 4535646750
| Date | Mar 29, 2021 |
| Status | Open, Classified |
| Reason | Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric values cease to update;e ECG |
| Root cause | Software design |
| Action | Philps issued Urgent Field Safety Field Notice-Medical Device Correction to or U.S. customers, the letters were sent via certified mail on 3/29/21. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Flex Cardio System. Because the issues listed above can be promptly identified by a qualified health care professional who has reviewed this notice and is closely observing the monitored patient, the Xper Flex Cardio may continue to be used if this step is taken. Resetting the device as desc |
| Quantity | 9208 units WW |
| Distribution | Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Bulgaria Canada Chile China Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Finland France Germany Greece Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Jordan Kazakhstan Kenya Korea, Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS Witt Biomedical Corp, Oct 26, 2010 |