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Class 3 Device Recall Guidant Zoom Latitude Programming System |
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Date Initiated by Firm |
May 19, 2006 |
Date Posted |
October 12, 2006 |
Recall Status1 |
Terminated 3 on December 31, 2006 |
Recall Number |
Z-0002-2007 |
Recall Event ID |
35672 |
PMA Number |
P910077 |
Product Classification |
Portable cardiac rhythm management system - Product Code LWS
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Product |
Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. |
Code Information |
Model 3120, serial numbers: 051089, 051449, 055130, 056463, 059146, 059334, 060912, 060961, 063612, 065790, |
Recalling Firm/ Manufacturer |
Guidant Corporation 4100 Hamline Ave N Saint Paul MN 55112-5700
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Manufacturer Reason for Recall |
Final software load did not occur prior to shipment of select programmers.
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FDA Determined Cause 2 |
Other |
Action |
Sales Representatives were asked to retrieve/return identified monitors. |
Quantity in Commerce |
8 |
Distribution |
Nationwide distribution --- including states of AR, MI, PA |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC
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