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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE Paceart Integration Software

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  Class 2 Device Recall LATITUDE Paceart Integration Software see related information
Date Initiated by Firm August 12, 2011
Date Posted October 12, 2011
Recall Status1 Terminated 3 on November 06, 2012
Recall Number Z-0037-2012
Recall Event ID 59898
PMA Number P910077 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product LATITUDE¿ Paceart Integration Software, version 1.00 Model 6472.

LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493.

When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.
Code Information software verson 1.00
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 has determined that under certain conditions, LATITUDE Paceart Integration (LPI) software may not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report.
FDA Determined
Cause 2		 Software design
Action Consignees were sent on 8/12/11 a Boston Scientific letter dated August 2011. The letter was addressed to "Dear Doctor". The letter described the product and problem. It also gave Background Information, Description of Potential Data Translation Error, and Additional Information and Action information. A letter, including an HRS form, was also sent to all US LATITUDE Clinics that have active LPI software to notify them of the need to install the corrected LPI Software.
Quantity in Commerce 398
Distribution Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT DE, DC, FL, GA, IL,IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OJ, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA,WV, WI, and WY.
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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