FDA recall Z-2521-2023

Diversatek Healthcare · Class III · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2023-07-25
Report date
2023-09-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Highlands Ranch, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2023