Diversatek Healthcare: ZVU Functional GI Software, REF: ZVU-3

Hazard

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

Details from the source

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. Quantity: 20 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

UPC codes

00816734022825

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.