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Recall Observatory FDA recall evidence

Device product

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

Z-0319-2021

September 22, 2020

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 86534
Status
Terminated
Classification
Class II
Quantity
8 devices
Official record key
device-enforcement:Z-0319-2021

Official wording

Reason: 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.

Code information: Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751

Distribution pattern: Distributed in US - AR, FL, IL, and TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.