Recall Z-2736-2018 ยท GZO Device, Galvanic Skin Response Measurement
Hudson Scientific LLC
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
| Date | Jul 2, 2018 |
| Status | Terminated |
| Reason | The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device. |
| Root cause | Nonconforming Material/Component |
| Action | On July 2, 2018, the firm notified customers of the recall via an emailed Urgent Medical Device Removal letter. Customers were informed that the company had received three complaints of electrical shock when using the device, and that the device and its accessories may not have been manufactured according to current good manufacturing practices. ACTIONS TO BE TAKEN BY THE CUSTOMER 1. Dispose of the iTOVi Scanner and its power adapter and charger in the trash. 2. Fill out and return to us the enclosed Attachment A: Urgent Removal Response Letter. The bottom of the form identifies three differe |
| Quantity | 35,949 units |
| Distribution | Nationwide distribution. Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.