ZYTO Technologies Recalls ZYTO Tower and Software for Regulatory Violations
ZYTO Technologies is voluntarily recalling ZYTO Tower devices and software because their marketing claims exceeded the scope of their FDA 510(k) clearance.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is driven by regulatory non-compliance (claims exceeding clearance) rather than a physical safety defect or reported injuries, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
ZYTO Technologies, Inc. is voluntarily recalling the ZYTO Tower input device and the ZYTO Select and Elite software. The recall is being conducted because the company's claims for these products exceeded the scope of their FDA 510(k) clearance.
The recall involves 1,252 units of the ZYTO Tower. The devices were distributed nationwide, as well as to Canadian and other foreign consignees. The source text does not indicate that any units were distributed to VA, government, or military channels.
Consumers who possess these devices or software should stop using them and contact ZYTO Technologies for further instructions on the recall process.
The recalled product
- Product
- The ZYTO Tower is the input device to program the software with various virtual items.
- Manufacturer
- ZYTO Technologies, Inc.
- Affected units
- 1,252
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ZYTO Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · ZYTO Technologies, Inc.
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FDA (Devices) · 2016-07-13
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