Home / Recalls / Medical Devices
Baxter Healthcare Corporation recalls Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Recalled July 8, 2020 · FDA recall Z-2474-2020 · Baxter Healthcare
Hazard
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. · FDA Class II
Units
60 units
Sold at
U.S. distribution only: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WI, WA, MI, CA.
Description
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Product
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →