FDA-Device2020-11-25Class II
VNS Therapy¿ AspireSR¿ Generator
LivaNova USA Inc
Hazard
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
Sold states
U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru
Affected count
134 generators
Manufactured in
100 Cyberonics Blvd, N/A, Houston, TX, United States
Products
VNS Therapy¿ AspireSR¿ Generator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0462-2021Don't want to check this manually?
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