LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Summary
The FDA issued a Class II for LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Softwa by Boston Scientific Corporation. 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-m.
Details
Source
Device Recall
External ID
Z-1216-2023
Action Date
2023-03-15
Status
Ongoing
Category
device
Product Description
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Lot/Code Info: UDI-DI: 00802526613876
Quantity Affected: 1,531 patient data records
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-02
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1216-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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