Recall – Implantable programmer unapproved software update

Company: Boston Scientific Corporation
Date of Enforcement Report: 3/25/2020
Class II

PRODUCT

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.

  • Recall Number: Z-1511-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Boston Scientific Corporation on 2/12/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

4 devices

DISTRIBUTION

US Nationwide

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