Company: Diversatek Healthcare
Date of Enforcement Report: 09/07/2023
Class III
PRODUCT
ZVU Functional GI Software, REF: ZVU-3
Recall Number:
Z-2521-2023
REASON:
GI software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
RECALLING FIRM/MANUFACTURER:
Diversatek Healthcare
VOLUME OF PRODUCT IN COMMERCE:
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.
