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.
FDA Recall Z-0037-2012 · Posted 2011-10-12
Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWS
Date Initiated2011-08-12
Date Terminated2012-11-06
Product Quantity398
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.