Company: Vitalconnect Inc.
Date of Enforcement Report: 7/15/2020
Class II
PRODUCT
A software graphical user interface intended for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring.
Recall Number: Z-2537-2020
REASON
Software defect.
RECALLING FIRM/MANUFACTURER
Vitalconnect Inc. on 5/21/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7
DISTRIBUTION
U.S. Nationwide