FDA recall Z-0913-2023

Medtronic Neuromodulation · Class II · device

Product

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C

Reason for recall

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-12-03
Report date
2023-01-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0913-2023