Z-2474-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- June 2, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
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.
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.
Code Information
Product Code: 5156-00000-011, All Serial numbers