FDA-Device2020-03-25Class II
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Boston Scientific Corporation
Hazard
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Sold states
US Nationwide distribution in the states of NC, TN, and MO.
Affected count
4 devices
Manufactured in
4100 Hamline Ave N Bldg 3, Saint Paul, MN, United States
Products
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1511-2020Don't want to check this manually?
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