ZVU Functional GI Software, REF: ZVU-3
Reported: September 13, 2023 Initiated: July 25, 2023 #Z-2521-2023
Product Description
ZVU Functional GI Software, REF: ZVU-3
Reason for Recall
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Details
- Recalling Firm
- Diversatek Healthcare
- Units Affected
- 20
- Distribution
- 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.
- Location
- Highlands Ranch, CO
Frequently Asked Questions
What product was recalled? ▼
ZVU Functional GI Software, REF: ZVU-3. Recalled by Diversatek Healthcare. Units affected: 20.
Why was this product recalled? ▼
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 13, 2023. Severity: Low. Recall number: Z-2521-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11