Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring Recalled by Invivo Corporation Due to While in Full Disclosure playback, a user may...

Date: November 20, 2017
Company: Invivo Corporation
Status: Ongoing
Source: FDA (Device)

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

Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.

Quantity: 1,040 units (USA) and 7 units (Foreign)

Why Was This Recalled?

While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Invivo Corporation

Invivo Corporation has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report