Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2121-2016·Announced 2016-07-13

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.

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 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: mis-labeling
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.

See all 2 products in this recall →

Same manufacturer · ZYTO Technologies, Inc.

See all →

Moderate
ZYTO Technologies Recalls ZYTO Tower and Software for Regulatory Violations
FDA (Devices) · 2016-07-13

Same hazard · mis labeling