Z-2121-2016 Class II Terminated
FDA device recall Z-2121-2016 was initiated by ZYTO Technologies, Inc. on November 23, 2015 and is designated Class II. Reason for recall: ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. The recall status is terminated (terminated December 21, 2017). Affected quantity: 1252 total.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2016
- Initiation Date
- November 23, 2015
- Termination Date
- December 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1252 total
Product Description
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).
Reason for Recall
ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
Distribution Pattern
Nationwide. Canadian and other foreign consignees. No VA/govt/military.
Code Information
Not Applicable.