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Recall Observatory FDA recall evidence

Device 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.

Z-2736-2018

July 02, 2018

Class II

Product summary

Firm
Hudson Scientific LLC
Event
Event 80483
Status
Terminated
Classification
Class II
Quantity
35,949 units
Official record key
device-enforcement:Z-2736-2018

Official wording

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.

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

Distribution pattern: Nationwide distribution. Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.