FDA Device recall Z-2521-2023
ZVU Functional GI Software, REF: ZVU-3
- FDA Device
- Class III
- ongoing
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class III recall of ZVU Functional GI Software, REF: ZVU-3 by Diversatek Healthcare, citing GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2521-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-07-25 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Diversatek Healthcare |
| Distribution | US |
Product
ZVU Functional GI Software, REF: ZVU-3
Reason
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Identifiers
| code_info | UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2521-2023%22
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