Class 3 Device Recall ZVU

• Date Initiated by Firm: July 25, 2023
• Date Posted: September 07, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2521-2023
• Recall Event ID: 92854
• 510(K)Number: K012232
• Product Classification: System, gastrointestinal motility (electrical) - Product Code FFX
• Product: ZVU Functional GI Software, REF: ZVU-3
• Code Information: UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023
• Recalling Firm/ Manufacturer: Diversatek Healthcare; 9150 Commerce Center Cir Ste 500; Highlands Ranch CO 80129-1563
• For Additional Information Contact: 303-470-7020
• Manufacturer Reason for Recall: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
• FDA Determined Cause: Labeling Change Control
• Action: Starting on 7/25/23 recall notices were mailed and emailed to customers asking them to do the following: 1) Discard affected product. 2) Contact customer service 1-800-558-6408 for replacement. 3) Complete and return the acknowledgement and receipt form.
• Quantity 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FFX