Z-2521-2023Class III

ZVU Functional GI Software, REF: ZVU-3

Name: Z-2521-2023 ZVU Functional GI Software, REF: ZVU-3
Creator: Diversatek Healthcare
Published: 2023-07-25
License: https://open.fda.gov/license/

Diversatek Healthcare Inc / initiated 2023-07-25 / Open, Classified / root cause: labeling and UDI

FDA source

Diversatek Healthcare began a recall of ZVU Functional GI Software, REF: ZVU-3 on 2023-07-25. FDA classified it as Class III and gives the reason as "GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2521-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-07-25
Posted: 2023-09-07
Recalling firm: Diversatek Healthcare Inc
Product: ZVU Functional GI Software, REF: ZVU-3
Product code: FFX System, Gastrointestinal Motility (Electrical)
Reason for recall: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2521-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2521-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-09-13	2023-09-07

Product code FFX

K012232Class IIInsight, Model S980000Sandhill Scientific, Inc. / cleared 2002-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)