Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
Philips is recalling 651 Xper Flex Cardio Physiomonitoring Systems because software defects may cause inaccurate waveform displays, frozen oxygen saturation values, or non-updating blood pressure readings.
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 is classified as FDA Class II. The hazard involves potential misdiagnosis due to inaccurate or frozen physiological data (SpO2, NIBP, waveforms), which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 651 units of the Xper Flex Cardio Physiomonitoring System, specifically software versions 1.5.16.0322 and 1.6.1.0390. The affected model numbers include 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, and 453564669081. The devices were distributed worldwide.
The recall addresses three specific software issues. First, under certain conditions, real-time waveforms may not be accurately plotted or displayed. Second, the oxygen saturation (SpO2) numeric value displayed on the device may freeze. Third, in auto cycle mode, if the non-invasive blood pressure (NIBP) communication is lost, the pump would not cycle and the NIBP numeric value displayed on the device would not update.
Healthcare facilities and users should check their device model numbers and software versions against the recall list. If a device is affected, users should contact Philips for instructions on how to obtain a software update or replacement. The source text does not report any illnesses or injuries associated with these defects.
The recalled product
- Product
- Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 651
Distribution
Distribution scope not specified by the agency.
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