Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1216-2023 — LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

U.S. FDA — Device Enforcement · United States · 2023-02-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1216-2023
Date of alert
2023-02-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00802526613876
Reported risk: 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..
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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