Recall Z-2115-2018— Invivo Corporation

Name: FDA recall Z-2115-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-20

Class II · Ongoing

Class II FDA medical device recall by Invivo Corporation, initiated 2017-11-20. It names one FDA 510(k) clearance: K101571. Product: 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.. Reason: 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..

Recalling firm: Invivo Corporation
Classification: Class II
Status: Ongoing
Initiated: 2017-11-20
Firm location: Orlando, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K101571 — XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMSWitt Biomedical Corp·cleared 2010-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.