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.
This recall has been terminated (originally issued October 12, 2011).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- August 12, 2011
- Posted
- October 12, 2011
- Terminated
- November 6, 2012
- Recall Number
- Z-0037-2012
- Quantity
- 398
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
software verson 1.00
Root Cause
Software design
Action Taken
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.