Summary
The FDA issued a Class III for ZVU Functional GI Software, REF: ZVU-3 by Diversatek Healthcare. Reason: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0..
Details
Source
Device Recall
External ID
Z-2521-2023
Action Date
2023-09-13
Status
Ongoing
Category
device
Product Description
ZVU Functional GI Software, REF: ZVU-3
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
Quantity Affected: 20
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-25
Company
Highlands Ranch, CO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Diversatek Healthcare has 8 FDA actions in our database, including 7 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Diversatek Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diversatek Healthcare have FDA actions?
Diversatek Healthcare has 8 FDA actions in our database, including 7 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2521-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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