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LivaNova USA Inc recalls VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Recalled December 18, 2019 · FDA recall Z-0663-2020 · LivaNova USA
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. · FDA Class II
Units
643 units
Sold at
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,
Description
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.
Product
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Manufacturer(s)
LivaNova USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →