Boston Scientific Corporation: LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

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..

Details from the source

Reason for recall: 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.. Distribution: 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. Quantity: 1,531 patient data records Lot/code info: UDI-DI: 00802526613876

UPC codes

00802526613876

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.