Z-2521-2023 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 13, 2023
- Initiation Date
- July 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
ZVU Functional GI Software, REF: ZVU-3
Reason for Recall
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
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.
Code Information
UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023