ZVU Functional GI Software recall: Software Issue
ZVU Functional GI Software, REF: ZVU-3
Why was ZVU Functional GI Software recalled?
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023
- Product
- ZVU Functional GI Software, REF: ZVU-3
- Recalling firm
- Diversatek Healthcare
- Quantity
- 20
- 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.
- Recall date
- September 13, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)