FDA-Device2020-07-08Class II
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Hazard
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Sold states
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.
Affected count
60 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2474-2020More Baxter Healthcare Corporation recalls
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- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
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