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U.S. Department of Health and Human Services

Class 3 Device Recall ZVU

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  Class 3 Device Recall ZVU see related information
Date Initiated by Firm July 25, 2023
Date Posted September 07, 2023
Recall Status1 Open3, 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 2		 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 and Original Applicant = SANDHILL SCIENTIFIC, INC.
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