FDA-Device2019-12-18Class II
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
LivaNova USA Inc
Hazard
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
Sold states
IL, AK, AL, AR, AZ, CA, CA , CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD MI, MN, MO, MS, MT, NC, ND, NE, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WA , WI, WV, WY,
Affected count
643 units
Manufactured in
100 Cyberonics Blvd, N/A, Houston, TX, United States
Products
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0663-2020Don't want to check this manually?
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