The Recall Desk
HighFDA (Devices)·Z-1517-2021·Announced 2021-05-05

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.

What this means for you

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 Xper
Manufacturer
Philips North America Llc
Category
Medical Device — Monitoring System
Hazard
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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