The Recall Desk
ModerateFDA (Devices)·Z-2521-2023·Announced 2023-09-13

ZVU Functional GI Software Recall for Incorrect Software Revision Labeling

ZVU Functional GI Software labeled as revision 3.3.0 is incorrectly labeled; it actually contains revision 3.2.0. The mislabeling affects 20 units distributed from May to July 2023.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall involving a minor revision labeling error. No illnesses or injuries have been reported, and the hazard is purely documentation-related. Per the severity rubric, minor labeling errors without reported harm are classified as Moderate.

Plain-English summary

Diversatek Healthcare has recalled ZVU Functional GI Software, REF: ZVU-3, due to incorrect revision labeling. The software shipped between May 4, 2023, and July 6, 2023, is labeled as revision 3.3.0 but actually contains revision 3.2.0.

The affected software was distributed in 12 U.S. states (New Jersey, Minnesota, Tennessee, Washington, Kentucky, Oregon, Florida, Georgia, New York, Texas, Colorado, and Kansas) and internationally in Japan and Saudi Arabia. Approximately 20 units are affected.

The recall addresses the discrepancy between the labeled software revision and the actual version present in the distributed units.

The recalled product

Product
ZVU Functional GI Software, REF: ZVU-3
Manufacturer
Diversatek Healthcare
Category
Medical Device — GI Diagnostic Software
Hazard
Affected units
20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Related recalls

Same manufacturer · Diversatek Healthcare

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