Recall Z-2572-2018 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA Inc
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
| Date | Jan 24, 2018 |
| Status | Terminated |
| Reason | Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. |
| Root cause | Software design (manufacturing process) |
| Action | Consignees were notified on about 01/24/2018 via URGENT: MEDICAL DEVICE CORRECTION letter. Instructions for physicians with new devices (interrogated for the first time) include to 1) apply the changes and proceed with programming as usual. The warning message requires a mandatory action to Apply Changes. After applying changes, therapy will automatically be programmed to 0 mA. The device may be immediately programmed back on to re-enable therapy. 2) To complete and return the attached Customer Response Form (by fax to (281) 853-1248 or by email to M3000FieldAction@livanova.com. Instruct |
| Quantity | 243 devices total |
| Distribution | Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.