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Recall Observatory FDA recall evidence

Device product

LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

Z-1216-2023

February 02, 2023

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 91646
Status
Ongoing
Classification
Class II
Quantity
1,531 patient data records
Official record key
device-enforcement:Z-1216-2023

Official wording

Reason: 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..

Code information: UDI-DI: 00802526613876

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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..