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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE Patient Management System

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  Class 2 Device Recall LATITUDE Patient Management System see related information
Date Initiated by Firm April 10, 2013
Date Posted May 20, 2013
Recall Status1 Terminated 3 on November 26, 2013
Recall Number Z-1339-2013
Recall Event ID 65096
PMA Number P910077S123 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product LATITUDE¿ Patient Management System, Model 6488, Version 7.3.

The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Code Information n/a
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 CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.
FDA Determined
Cause 2		 Software change control
Action Boston Scientific CRM Corp began re-faxing the 4,912 previously illegible PMR notifications on April 10, 2013 and completed on April 15, 2013, successfully fulfilling labeling expectations that these notifications be communicated to the clinic. For questions regarding this recall call 651-582-4000.
Quantity in Commerce 1
Distribution Nationwide Distribution including DC and PR
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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