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U.S. Department of Health and Human Services

Class 2 Device Recall iTOVi

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  Class 2 Device Recall iTOVi see related information
Date Initiated by Firm July 02, 2018
Create Date August 08, 2018
Recall Status1 Terminated 3 on January 13, 2020
Recall Number Z-2736-2018
Recall Event ID 80483
Product Classification Device, galvanic skin response measurement - Product Code GZO
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.
Code Information 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
Recalling Firm/
Manufacturer		 Hudson Scientific LLC
103 W Main St
Hudson MI 49247-1022
For Additional Information Contact Mr. George G. Calafactor
877-483-3748
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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