27

Sep

2018

Recall – Cl II Model 3300 LATITUDE(TM) Programming System

0

Company: Boston Scientific Corporation
Date of Enforcement Report 10/3/2018
Class II:

PRODUCT
Model 3300 LATITUDE(TM) Programming System 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.

Serial Numbers: 001343 000488 000903 001404 000923 001352 001441 000203 000224 000255 000284 000434 000441 000445 000501 000515 000519 000521 000534 000536 000546 000553 000578 000588 000601 000602 000605 000606 000609 000610 000616 000617 000620 000628 000631 000633 000634 000636 000637 000638 000643 000644 000661 000664 000666 000667 000669 000671 000673 000677 000679 000682 000688 000690 000691 000700 000710 000717 000719 000720 000723 000726 000746 000757 000765 000924 001125 001556 001562 001564 001571 001574 001615 000598

Recall Number: Z-3260-2018

REASON
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.

RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Saint Paul, MN on 9/10/2018 Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
74

DISTRIBUTION
Worldwide distribution – US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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