Class 2 Device Recall Philips Physiomonitoring system

• Date Initiated by Firm: March 29, 2021
• Create Date: April 29, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1517-2021
• Recall Event ID: 87732
• 510(K)Number: K101571
• Product Classification: Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
• Product: 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
• Code Information: Service Number/ UDI # 453564241901 (01)00884838082113; 453564241911 (01)00884838082113; 453564483321 (01)00884838082113; 453564483331 (01)00884838083516; 453564621791 (01)00884838084902; 453564621801 (01)00884838084919; 453564845881 (01)00884838095052; 453564675021 (01)00884838103245; 453564669081 (01)00884838083820; 453564675001 (01)00884838086005; 453564674581 (01)00884838083820; 453564845841 (01)00884838093645; 453564845861 (01)00884838093652
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer Reason for Recall: 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, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform, erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor
• FDA Determined 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 described in the IFU (Section 4, page 87), is likely to return the device to normal operation, which takes approximately 3-5 minutes. To reset your Flex Cardio device, close any patient cases and then turn the power switch off (see back of device for the power switch). Wait 510 seconds then turn the power switch back on. Allow the device to fully restart and restore the monitoring display. Please complete and return the Customer Reply Form included on the last page of this communication indicating your receipt and understanding of this information. Philips will provide a software update for the Xper Flex Cardio to correct all but, issue #7 above at no charge. A Philips representative will contact you when the software is available for installation. Philips has also added directions to the IFU for the Xper Flex Cardio on how to reset the device in the event that the user observes issue #7 above. An IFU addendum with the directions will be provided to all affected users when it becomes available. If you need any further information or support concerning this issue, please contact your local Philips representative: 800-669-1328 option 2, then option 3.
• Quantity in Commerce: 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, Republic of Kuwait Latvia Lebanon Libya Lithuania Malaysia Mauritius Mexico Mongolia Morocco Myanmar Nepal Netherlands New Caledonia New Zealand Nigeria Norway Oman Pakistan Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico R¿union Romania Russian Federation Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey United Arab Emirates United Kingdom Uzbekistan Viet Nam Yemen
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MWI