Recall – Wireless remote monitoring system software defect

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

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