Z-2474-2020 Class II Ongoing
FDA device recall Z-2474-2020 was initiated by Baxter Healthcare Corporation on Jun 2, 2020 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 60 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 8, 2020
- Initiation Date
- Jun 2, 2020
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2474-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026