CLASS III ONGOING Device recall · Reported 13 Sep 2023 · FDA Enforcement Report

ZVU Functional GI recalled by Diversatek Healthcare

Diversatek Healthcare is recalling ZVU Functional GI, distributed nationwide in the US. The recall was initiated on 25 Jul 2023 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023

Quantity recalled20

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2521-2023
FDA event ID: 92854
Recalling firm: Diversatek Healthcare, Highlands Ranch, CO
Classification: Class III
Status: Ongoing
Recall initiated: 25 Jul 2023
FDA classified: 7 Sep 2023
Reported: 13 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Medical Software

Timeline

25 Jul 2023	Recall initiated by company
7 Sep 2023	Classified by FDA	+44 days
13 Sep 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

Product as listed by the FDA

ZVU Functional GI Software, REF: ZVU-3

Where it was distributed

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.

Nationwide Colorado Florida Georgia Kansas Kentucky Minnesota New Jersey New York Oregon Tennessee Texas Washington

Questions about this recall

Why was it recalled?

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

Which lots are affected?

UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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