Reported Sep 13, 2023 · Ongoing
ZVU Functional GI Software, REF: ZVU-3
Diversatek Healthcare
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diversatek Healthcare · 9150 Commerce Center Cir Ste 500 · Highlands Ranch, CO · 80129-1563
Is this the product you have?
- ZVU Functional GI Software
- REFZVU-3
- Lot codes and dates
- UDI-DI00816734022825
- REV3.3.0
- Software Version
3.3.2109.6Shipped between 5/4/2023 and 7/6/2023
- Amount recalled
- 20
Where it was sold
Why it was recalled
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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