Boston Scientific Corporation recalls Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming S…

Recall date

February 12, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1511-2020

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

US Nationwide distribution in the states of NC, TN, and MO.

Why it was recalled

Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.