Recall Z-0263-2018— Invivo Corporation

Name: FDA recall Z-0263-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-18

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2017-08-18, terminated 2024-09-20. It names one FDA 510(k) clearance: K101571. Product: Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.. Reason: Intermittent communication between the host system and the FlexCardio.

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-08-18
Terminated: 2024-09-20
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. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.

Reason for recall

Intermittent communication between the host system and the FlexCardio

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