FDA-Device2023-03-15Class II
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Boston Scientific Corporation
Hazard
Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..
Sold states
US Nationwide distribution to the healthcare facilities and healthcare providers are located in CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, ME, MD, MA, NV, NH, NJ, NY, NC, OH, PA, RI, SC, TN TX, VA, WA, WV, and WI.
Affected count
1,531 patient data records
Manufactured in
4100 Hamline Ave N, Saint Paul, MN, United States
Products
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2023Don't want to check this manually?
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