Z-1216-2023 Class II Ongoing
FDA device recall Z-1216-2023 was initiated by Boston Scientific Corporation on February 2, 2023 and is designated Class II. 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 He… The recall status is ongoing. Affected quantity: 1,531 patient data records.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- February 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,531 patient data records
Product Description
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
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 Pattern
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.
Code Information
UDI-DI: 00802526613876