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U.S. Department of Health and Human Services

Class 3 Device Recall Latitude Patient Management System

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 Class 3 Device Recall Latitude Patient Management Systemsee related information
Date Initiated by FirmDecember 19, 2011
Date PostedFebruary 23, 2012
Recall Status1 Terminated 3 on October 25, 2012
Recall NumberZ-1096-2012
Recall Event ID 60945
PMA NumberP910077 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
ProductLATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Code Information Software version 7.2
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
651-582-4000
Manufacturer Reason
for Recall		Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.
FDA Determined
Cause 2		Software design
ActionBeginning on December 19, 2011, for the patients that have attempted to set-up their communicators, Boston Scientific called the patients and their associated LATITUDE clinics to let them know that they can now complete the set-up.
Quantity in Commerce1
DistributionNationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LWS
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