Health product recall

Zoom Latitude Programmer/Recorder/Monitor (Prm)

Last updated

Summary

Product
Zoom Latitude Programmer/Recorder/Monitor (Prm)
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Zoom Latitude Programmer/Recorder/Monitor (Prm) More than 10 numbers, contact manufacturer. 3120

Issue

Boston Scientific Corporation is initiating an advisory to inform customers that if limited supply of model 3300 latitude programmers exists locally, Boston Scientific recommends continued use of older model 3120 zoom programmers. Consequently, users may observe some unanticipated behaviors not described in labeling if certain transvenous (tv) defibrillators are interrogated with outdated model 2868 software on 3120 zoom programmers. The purpose of this letter is to describe potential interactions between tv defibrillators and the 2868 software installed on 3120 zoom programmers. These potential interactions do not alter tv defibrillation operation or programming.

Recall start date: July 7, 2022

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Boston Scientific Corporation

4100 Hamline Avenue North, St. Paul, Minnesota, United States, 55112-5798

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64392