medical Class II Updated 2020-07-08

Baxter Healthcare Corporation recalls Flow Coupler Monitor, GEM, Global Excellence Microsurgery, R

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WA, CA
Lot/Code Info: Product Code: 5156-00000-011, All Serial numbers
View official government recall

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