Philips Xper Flex Cardio recall: Software Issue
Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for…
Why was Philips Xper Flex Cardio recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for…
- Recalling firm
- Philips North America Llc
- 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, 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
- Recall date
- May 5, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)