Device product
ZVU Functional GI Software, REF: ZVU-3
Z-2521-2023
Product summary
- Event
- Event 92854
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 20
- Official record key
device-enforcement:Z-2521-2023
Official wording
Reason: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Code information: UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023
Distribution pattern: worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia.
Derived failure modes
-
Labeling or packaging
incorrectly labeled