Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2474-2020

June 02, 2020

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 85782
Status
Ongoing
Classification
Class II
Quantity
60 units
Official record key
device-enforcement:Z-2474-2020

Official wording

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

Code information: Product Code: 5156-00000-011, All Serial numbers

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    firmware issue