Philips Recalls Xper Flex Cardio Monitors Due to Performance Issues
Philips is recalling Xper Flex Cardio monitors due to software issues that may cause display delays, freezing, or incorrect data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with performance issues that could lead to incorrect monitoring data, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling approximately 9,208 units of the Xper Flex Cardio (FC2010 and FC2020) physiologic monitoring systems. These devices are intended for use by professional healthcare providers for complete physiologic and hemodynamic monitoring. The recall covers units distributed nationwide and in numerous foreign countries.
The recall is due to performance issues with the Xper Flex Cardio Physio Monitoring System. These issues include potential delays of up to 10 seconds in displaying ECG, invasive blood pressure, and other parameters. Additionally, patient weight may be rounded to the nearest whole kilogram, and the Xper IM software may periodically crash. Other reported issues include the failure to display SpO2 numeric or plethysmography data, frozen display of certain data, and the appearance of flat lines or non-physiological waveforms upon startup without audible alarms.
Healthcare providers should contact Philips for instructions on how to address these performance issues. The source text does not specify a specific action for consumers, as the devices are intended for professional use.
The recalled product
- 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…
- Manufacturer
- Philips North America Llc
- Affected units
- 9,208
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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
Distribution
Distributed nationwide across the United States.
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