Device product
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Z-2474-2020
Product summary
- 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
firmware issue