Company: ZYTO Technologies Inc. Date of Enforcement Report 7/13/2016 Class lI: PRODUCT The ZYTO Tower is the input device to program the software with various virtual items. Recall Number Z-2120-2016 REASON 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....Read More

Company: ZYTO Technologies Inc. Date of Enforcement Report 7/13/2016 Class lI: 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). Recall...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 7/13/2016 Class lI: PRODUCT VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through...Read More

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure .Date of Enforcement Report 7/13/2016 Class lI: PRODUCT Medtronic, MyCareLink” Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician. Recall Number Z-2125-2016...Read More