Hudson Scientific LLC: Medical Device Recall in 2018 - (Recall #: Z-2736-2018)
See the recall detail below. You can also see other recalls from the same firm in 2018.
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.
Class II
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.
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
Nationwide distribution. Worldwide distribution.
Voluntary: Firm initiated