Diversatek Healthcare ZVU-3 GI Software Recall: Incorrect Revision Label

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Contact the company & request your remedy

Recalling firmDiversatek Healthcare9150 Commerce Center Cir Ste 500, N/A · Highlands Ranch, CO 80129-1563

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Diversatek Healthcare is recalling ZVU-3 Functional GI Software that has an incorrect revision label (marked as 3.3.0 but is actually 3.2.0). This labeling error doesn't affect safety but may cause confusion about software versions.

Why it’s dangerous

The software is labeled as revision 3.3.0 but is actually revision 3.2.0. This labeling error could lead to confusion about which version is installed, potentially causing incorrect software behavior or compatibility issues.

Who’s affected

Users of Diversatek Healthcare's ZVU-3 GI software who received it between May 4, 2023 and July 6, 2023. Healthcare providers using this software are most at risk of version confusion.

How to tell if you have this one

Check for the software version label: 'ZVU-3, REV: 3.3.0, Software Version: 3.3.2109.6'. This version was shipped between May 4, 2023 and July 6, 2023.

Brand
Diversatek Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version label on your device to confirm it matches the correct revision.

✎ GovInfoNow

Questions people ask

Is this software dangerous?

No, this is a labeling error that does not pose a safety risk but may cause confusion about software versions.

Do I need to do anything with this software?

No action is required as this is a labeling error that does not affect safety.

When was this software shipped?

This software was shipped between May 4, 2023 and July 6, 2023.

Take action

Contact Diversatek Healthcare

We’ve drafted a message you can send Diversatek Healthcare to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2521-2023 — Diversatek Healthcare Diversatek Healthcare

Hello,

I own a Diversatek Healthcare that is covered by recall Z-2521-2023 from Diversatek Healthcare.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2521-2023 (July 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2521-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Diversatek Healthcare recalls ZVU Functional GI Software, REF: ZVU-3

Lower-risk recall