Recall Z-0663-2020 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA Inc
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
| Date | Nov 16, 2018 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On November 16, 2018 LivaNova mailed a "Medical Device Correction" letter via 1st class mail to affected Doctors informing them about the recall. The letter asked doctor's to do the following: 1.When performing System Diagnostics on patients implanted with a Model 102 or 102R generator, do one of the following: a. Use any of the following Programming System software versions: Model 250 8.1/11.0; Model 3000 version 1.0; or b. If one of the above Programming Systems software versions is not available, complete the following steps to perform System Diagnostics using Model 3000 version 1.5 softwa |
| Quantity | 643 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.