Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Reported: July 8, 2020 Initiated: June 2, 2020 #Z-2474-2020
Product Description
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Reason for Recall
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 60 units
- Distribution
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only. Recalled by Baxter Healthcare Corporation. Units affected: 60 units.
Why was this product recalled? ▼
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2474-2020.
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