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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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