FDA recall Z-2572-2018

Product

VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2

Reason for recall

Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.

Distribution

Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.

Key facts

Status

Terminated

Initiation date

2018-01-24

Report date

2018-08-08

Termination date

2023-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2572-2018