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U.S. Department of Health and Human Services

Class 3 Device Recall Guidant Zoom Latitude Programming System

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  Class 3 Device Recall Guidant Zoom Latitude Programming System see related information
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
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
Manufacturer Reason
for Recall		 Final software load did not occur prior to shipment of select programmers.
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
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.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC
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