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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.