Reported Mar 15, 2023 · Ongoing
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
- Lot codes and dates
- UDI-DI00802526613876
- Amount recalled
- 1,531 patient data records
Where it was sold
Why it was recalled
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..
This product could cause temporary or reversible health problems — stop using it.
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