FDA-Device2022-09-07Class II
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
Boston Scientific Corporation
Hazard
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Sold states
Worldwide Distribution
Affected count
17,172 units in total
Manufactured in
4100 Hamline Ave N, Saint Paul, MN, United States
Products
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1670-2022Don't want to check this manually?
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