FDA-Device2020-02-19Class II
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
LivaNova USA Inc
Hazard
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
Sold states
US: FL, GA, KS, MO, and UT. No OUS distribution
Affected count
6 generators
Manufactured in
100 Cyberonics Blvd, Houston, TX, United States
Products
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2020Don't want to check this manually?
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