Philips recalls Xper Flex Cardio (FC2010/FC2020) monitors for possible display delays, data errors, and flat-line readings that could affect patient monitoring accuracy.
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
Philips is recalling Xper Flex Cardio monitors used in hospitals for patient monitoring. These devices may show delayed readings, incorrect weight calculations, software crashes, missing SpO2 data, or flat-line displays that could lead to missed critical health changes.
The monitors may delay displaying critical patient data by up to 10 seconds, round patient weight to the nearest kilogram, crash unexpectedly, miss SpO2 readings, or show flat-line waveforms without alarms. This could lead to delayed detection of serious health issues.
Healthcare providers using Philips Xper Flex Cardio (FC2010 or FC2020) monitors for patient monitoring. Patients are at risk if the device fails to accurately track vital signs during critical medical procedures.
Check for service numbers listed in the recall: FC2010 models with service numbers like 453564241901 or FC2020 models with numbers like 453564241911. The software version is 1.5.19 or 1.6.8.
Look for the service number on the device label, which matches the numbers listed in the recall (e.g., 453564241901 for FC2010).
FC2010 (Procedure Room) and FC2020 (Bedside) monitors with service numbers starting with 453564241901 or similar as listed in the recall.
The monitors may show delayed readings, incorrect weight calculations, software crashes, missing SpO2 data, or flat-line displays that could affect patient monitoring accuracy.
No. The recall does not require immediate discontinuation; healthcare providers should check the service number and monitor for issues.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1517-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-1517-2021 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
