Z-2736-2018Class II

iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The...

Name: Z-2736-2018 iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The...
Creator: Hudson Scientific LLC
Published: 2018-07-02
License: https://open.fda.gov/license/

Hudson Scientific LLC / initiated 2018-07-02 / Terminated / root cause: manufacturing process

FDA source

Hudson Scientific LLC began a recall of 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... on 2018-07-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2736-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-02
Posted: 2018-08-08
Terminated: 2020-01-13
Recalling firm: Hudson Scientific LLC
Product: 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.
Product code: GZO Device, Galvanic Skin Response Measurement
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 35,949 units
Distribution: Nationwide distribution. Worldwide distribution.
Product codes and lots: Device Lot/ Batch Numbers: 012016, 032016, 112016, 122016, 012017, 022017, 032017, 092017, 112017, 012018 Device Serial Numbers: 35,949 MAC Numbers ranging from 0F:72: D9:E9: F4:5A to FF: FF: AB:37: 7A:0C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2736-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2736-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-08

Product code GZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)