FDA-Device2020-11-11Class II
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Boston Scientific Corporation
Hazard
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.
Sold states
Distributed in US - AR, FL, IL, and TX
Affected count
8 devices
Manufactured in
4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, United States
Products
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0319-2021Don't want to check this manually?
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