Z-1216-2023Class II

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

Name: Z-1216-2023 LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460
Creator: Boston Scientific Corporation
Published: 2023-02-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2023-02-02 / Open, Classified / root cause: software

FDA source

Boston Scientific Corporation began a recall of LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460 on 2023-02-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1216-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-02
Posted: 2023-03-03
Recalling firm: Boston Scientific Corporation
Product: LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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..
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: The recalling firm issued letters to LATITUDE Healthcare Professionals via third-party Federal Express with signature at the account required on 2/2/2023. The letter informed the HCP that records indicate they may have U.S. patients who do not have HeartLogic enabled as the HCP may have intended in the Model 6460 U.S. LATITUDE NXT Patient Management System. The patients included within the enclosed list are scheduled to have HeartLogic enabled in LATITUDE ON 2/14/2023. The letter provides the clinical impact and recommendations. The recommendations include: (1) Distribute this information to appropriate HCPs within your center who manage HeartLogic alerts for the patients in the enclosed list; and (2) If you do NOT want HeartLogic enabled in LATITUDE for patients in the enclosed list, contact Boston Scientific LATITUDE Customer Support via [email protected] before 2/14/2023 and identify which patients should NOT be enabled. On 2/14/2023, BSC will correct the data on the Model 6460 LATITUDE Server for affected patients, unless a request not to enable is received by the firm prior to this date. Update: on 02/14/2023, Boston Scientific sent an additional letter, due to the original letter being lost in the mail. The revised letter advised customers to email LATITUDE Custoemr Support to have HeartLogic disabled.
Quantity in commerce: 1,531 patient data records
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.
Product codes and lots: UDI-DI: 00802526613876

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1216-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1216-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-03

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)