LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore d

FDA device recall Z-0037-2012 · posted 2011-10-12 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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.

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.

Root cause

Software design

Status

Terminated

Product code

LWS

Quantity affected

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,

Date initiated

2011-08-12

Date posted

2011-10-12

Date terminated

2012-11-06

Location

Saint Paul, MN