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Terminated

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.

FDA Recall Z-2736-2018 · Posted None

Recalling FirmHudson Scientific LLC
Recall StatusTerminated
Product CodeGZO
Date Initiated2018-07-02
Date Terminated2020-01-13
Product Quantity35,949 units

Reason for Recall

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.

Firm 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 different methods of returning this form to iTOVi. 3. Forward this letter to any users to whom you may have distributed the device. 4. If you or others have encountered any illnesses or injuries during or after use of any iTOVi Tracker/ Scanner products, iTOVi recommends that you arrange for yourself and other product users to seek medical attention. TYPE OF ACTION BY THE COMPANY: As of June 15, 2018, all iTOVi Tracker/ Scanner software applications (apps) will be deactivated via the following steps: 1. Using the server-based software that handles iTOVi account logins, iTOVi will disable the iTOVi computer software application that runs on iOS and Android operating systems for all iTOVi devices. 2. iTOVi will issue an update to the iTOVi software application which displays a message saying that the iTOVi Scanner device is no longer usable and should be disposed of in the trash. iTOVi is in the process of creating a more reliable, innovative iTOVi Scanner, and will be sending out a new device to replace older models.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution. Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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