Lower risk Medical device recall · FDA · Published March 29, 2021

Philips Xper Flex Cardio Monitors: Potential Display Delays and Data Errors

Philips recalls Xper Flex Cardio (FC2010/FC2020) monitors for possible display delays, data errors, and flat-line readings that could affect patient monitoring accuracy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1517-2021Medical device Philips ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/62895-philips-xper-flex-cardio-monitors-potential-display-delays-and-data.

Source Summary by GovInfoNow · govinfonow.com/recall/62895-philips-xper-flex-cardio-monitors-potential-display-delays-and-data · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1517-2021

Cite this page

“Philips Xper Flex Cardio Monitors: Potential Display Delays and Data Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62895-philips-xper-flex-cardio-monitors-potential-display-delays-and-data. Based on FDA recall #Z-1517-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1517-2021%22&limit=1).

The FDA announced on March 29, 2021, that Philips North America LLC voluntarily recalled Xper Flex Cardio monitoring devices due to performance issues including delayed parameter displays and software crashes. Owners should contact Philips for a remedy.

How to tell if you have it

Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices
Service numbers: 453564241901, 453564483321, 453564621791, 453564675021, 453564669081, 453564674581, 453564845841, 453564845881, 453564241911, 453564483331, 453564621801, 453564675001, 453564845861
Software versions: 1.5.19 and 1.6.8
UPCs: 00884838082113, 00884838083516, 00884838083820, 00884838084902, 00884838084919, 00884838086005, 00884838093645, 00884838093652, 00884838095052, 00884838103245

The hazard

According to the FDA, performance issues with the Xper Flex Cardio Physio Monitoring System include potential delays in displaying ECG and blood pressure parameters, patient weight rounding errors, periodic software crashes, and missing SpO2 displays. The record states that waveforms may freeze or become flat lines without audible alarms, and unexpected non-physiological data may appear upon startup.

Context

GovInfoNow's records show Philips North America LLC has 129 other recalls on file since July 12, 2017. Recent brand recalls include an August 21, 2026 recall of Achieva 1.5T systems for software termination issues and an August 18, 2026 recall of Spectral CT 7500 Scanners for potential extra radiation exposure. Other recent recalls of similar products include a July 31, 2026 recall of Philips PIC iX Essentials Software for patient data issues, an August 6, 2026 recall of Boston Scientific LUX-Dx Cardiac Monitor Systems for delayed alerts, and a March 30, 2026 recall of Boston Scientific LUX-DX II Arrhythmia Detectors for missing heart monitoring data.

How to tell if you have this one

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.

Brand
Philips
Product
Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Service Number
Look for the service number on the device label, which matches the numbers listed in the recall (e.g., 453564241901 for FC2010).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

Mar 29, 2021Firm started the recall
Apr 29, 2021FDA classified it Class II
May 5, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What models are affected?

FC2010 (Procedure Room) and FC2020 (Bedside) monitors with service numbers starting with 453564241901 or similar as listed in the recall.

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Link to this recall

<a href="https://govinfonow.com/recall/62895-philips-xper-flex-cardio-monitors-potential-display-delays-and-data">Philips Xper Flex Cardio Monitors: Potential Display Delays and Data Errors (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1517-2021 (March 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1517-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.