Recall – Monitor shuts down when WiFi connection not established

Company: Baxter Healthcare Corporation
Date of Enforcement Report: 7/8/2020
Class II

PRODUCT

Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

Recall Number: Z-2474-2020

REASON

A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.

RECALLING FIRM/MANUFACTURER

Baxter Healthcare Corporation on 6/2/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

60 units

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.