ZVU Functional GI Software, REF: ZVU-3
FDA device recall Z-2521-2023 · posted 2023-09-07 · Open, Classified
Recall details
- Recalling firm
- Diversatek Healthcare
- Reason for recall
- GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- FFX
- Quantity 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.
- Date initiated
- 2023-07-25
- Date posted
- 2023-09-07
- Location
- Highlands Ranch, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSIGHT, MODEL S980000 (K012232) | Sandhill Scientific, Inc. | 2002-06-07 |