FDA Recalls iTOVi Tracker/Scanner Devices Due to Shock Complaints
Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported electric shocks, which constitutes a significant injury risk under the severity rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15, manufactured by Hudson Scientific LLC. These devices are intended to rank galvanic skin response measurements and generate reports recommending nutritional supplements. The recall involves 35,949 units that were distributed nationwide and worldwide.
The recall was initiated because the devices and their accessories may not have been manufactured according to current Good Manufacturing Practices. Additionally, the firm has received three complaints regarding electric shocks received when using the device.
Consumers who possess these devices should stop using them immediately. Hudson Scientific LLC is the recalling firm responsible for managing the recall process.
The recalled product
- 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.
- Manufacturer
- Hudson Scientific LLC
- Affected units
- 35,949
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distributed nationwide across the United States.
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