Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2474-2020 — Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

U.S. FDA — Device Enforcement · United States · 2020-06-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2474-2020
Date of alert
2020-06-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Reported risk: A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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