ZYTO Software Recalled for Exceeding 510(k) Clearance Claims
ZYTO Technologies is voluntarily recalling ZYTO Tower and software programs because their claims exceeded the scope of their FDA 510(k) clearance.
What this means for you
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 involves a regulatory compliance issue (claims exceeding clearance) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
ZYTO Technologies, Inc. is voluntarily recalling the ZYTO Tower and ZYTO Select and Elite software programs. The recall was initiated because the claims made for these products exceeded the scope of their FDA 510(k) clearance.
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent to least coherent. A total of 1,252 units were distributed nationwide, as well as to Canadian and other foreign consignees. No units were distributed to VA, government, or military channels.
This recall is classified as Class II by the FDA. Consumers and users of these software programs should stop using them and contact ZYTO Technologies for further instructions regarding the recall.
The recalled product
- Product
- The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).
- Manufacturer
- ZYTO Technologies, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 1,252
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 (1)
- Not Applicable.
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.
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