FDA Device recall Z-1216-2023
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460 by Boston Scientific, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1216-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-02 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
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..
Identifiers
| code_info | UDI-DI: 00802526613876 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1216-2023%22
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