Recall Z-2474-2020 ยท MVR Device, Anastomotic, Microvascular
Baxter Healthcare Corporation
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
| Date | Jun 2, 2020 |
| Status | Open, Classified |
| Reason | A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. |
| Root cause | Device Design |
| Action | Synovis Micro Companies Alliance (MCA), Inc., a subsidiary of Baxter International Inc., sent a notification to healthcare providers dated, June 2, 2020 titled, "Urgent Medical Device Recall". The notification was sent to the user level for the GEM1020M-2 Flow Coupler Monitor due to a firmware issue which may cause the monitor to intermittently shut down when a WiFi connection is not established. If a shutdown occurs, the monitor can be manually powered back on and will resume normal operation. Synovis is requesting the return of the monitors to perform a firmware upgrade to resolve the issue |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191252 | Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance, Inc., Jul 9, 2019 |