ZVU Functional GI Software, REF: ZVU-3
This recall is currently active, issued September 7, 2023. It was issued by Diversatek Healthcare.
- Company
- Diversatek Healthcare
- Recall Initiated
- July 25, 2023
- Posted
- September 7, 2023
- Recall Number
- Z-2521-2023
- Quantity
- 20
- Firm Location
- Highlands Ranch, CO
- Official Source
- View on FDA website ↗
Reason for Recall
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Distribution
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.
Lot / Code Info
UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023
Root Cause
Labeling Change Control
Action Taken
Starting on 7/25/23 recall notices were mailed and emailed to customers asking them to do the following: 1) Discard affected product. 2) Contact customer service 1-800-558-6408 for replacement. 3) Complete and return the acknowledgement and receipt form.