FDA recall Z-0319-2021

Product

Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application

Reason for recall

There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.

Distribution

Distributed in US - AR, FL, IL, and TX

Key facts

Status

Terminated

Initiation date

2020-09-22

Report date

2020-11-11

Termination date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0319-2021