Recall Z-2521-2023 ยท FFX System, Gastrointestinal Motility (Electrical)
Diversatek Healthcare
ZVU Functional GI Software, REF: ZVU-3
| Date | Sep 7, 2023 (initiated Jul 25, 2023) |
| Status | Open, Classified |
| Reason | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012232 | INSIGHT, MODEL S980000 Sandhill Scientific, Inc., Jun 7, 2002 |