Recall Z-2760-2016— Invivo Corporation

Name: FDA recall Z-2760-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-19

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2015-10-19, terminated 2019-10-04. It names one FDA 510(k) clearance: K101571. Product: The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.. Reason: Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze.

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-10-19
Terminated: 2019-10-04
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

The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.

Reason for recall

Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze

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