Zvu recallZ-2521-2023 · Diversatek Healthcare · initiated Jul 25, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diversatek Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
FDA root cause category: Labeling Change Control
What the company is doing
Starting on 7/25/23 recall notices were mailed and emailed to customers asking them to do the following: 1) Discard affected product. 2) Contact customer service 1-800-558-6408 for replacement. 3) Complete and return the acknowledgement and receipt form.
Recall details
- Recall number
- Z-2521-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 25, 2023
- Posted by the FDA
- Sep 7, 2023
- Recalling firm
- Diversatek Healthcare
- Quantity
- 20
- Product code
- FFX
- FDA submissions
- K012232
- 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.
Product description
ZVU Functional GI Software, REF: ZVU-3
Code information (models, lots, serial numbers)
UDI-DI: 00816734022825, REV: 3.3.0, Software Version: 3.3.2109.6, Shipped between 5/4/2023 and 7/6/2023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zvu® ZVU-3Diversatek Healthcare, Inc. · System, Gastrointestinal Motility (Electrical)1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K012232 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- inSIGHT Ultima H12R-2000Diversatek Healthcare, Inc. · System, Gastrointestinal Motility (Electrical)1 report
- ZepHr Z07-2000-B-BDiversatek Healthcare, Inc. · System, Gastrointestinal Motility (Electrical)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page