Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PHILIPS Xper Flex Cardio Physiomonitoring System Recalled by Invivo Corporation Due to The real-time numeric value for ventricular end-diastolic pressure...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Invivo Corporation directly.
Affected Products
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.
Quantity: 4375 units
Why Was This Recalled?
The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Invivo Corporation
Invivo Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report