Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended ...
FDA Device Recall #Z-1517-2021 — Class II — March 29, 2021
Recall Summary
| Recall Number | Z-1517-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 29, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America Llc |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 9208 units WW |
Product Description
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
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
Distribution Pattern
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
Lot / 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
Other Recalls from Philips North America Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1316-2026 | Class II | IQon Spectral CT; Product Code (REF): 728332; | Jan 7, 2026 |
| Z-1318-2026 | Class II | Spectral CT 7500 on Rails; Product Code (REF):... | Jan 7, 2026 |
| Z-1317-2026 | Class II | Spectral CT; Product Code (REF): 728333; | Jan 7, 2026 |
| Z-1315-2026 | Class II | Brilliance iCT; Product Code (REF): 728306; | Jan 7, 2026 |
| Z-1033-2026 | Class II | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient M... | Dec 12, 2025 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.