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Terminated

LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1. Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements.

FDA Recall Z-0333-2012 · Posted 2011-12-01

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWS
Date Initiated2011-10-12
Date Terminated2012-12-04
Product Quantity25,300 (14,700 US; 10,600 OUS)

Reason for Recall

Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LATITUDE (if activated). However, the mea

Firm Action

Boston Scientific sent an "IMPORTANT DIAGNOSTIC INFORMATION" letter dated October 2011 to all affected customers. The letter described the product, problem and actions to be taken by the customers.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, CANADA, AUSTRALIA, NEW ZEALAND, CYPRUS, CZECH REPUBLIC, GREECE, GUADELOUPE, HUNGARY, BANGLADESH, CHINA, COCOS ISLAND, HONG KONG, INDIA, INDONESIA, KOREA, MALAYSIA, PHILIPPINES, SINGAPORE, SOUTH KOREA, SRI LANKA, THAILAND, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, NEW CALEDONIA, POLAND, PORTUGAL, QATAR, REUNION,IRAN, ISRAEL, JORDAN, KUWAIT, LATVIA, LEBANON, LUXEMBOURG, MONACO, MOROCCO, JAPAN, ARGENTINA, ARUBA, BAHAMAS, BARBADOS, BELIZE, BERMUDA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, FALKLAND ISLANDS, HAITI, HONDURAS, JAMAICA, MEXICO, PANAMA, PERU, TRINIDAD & Tobago, URUGUAY, VENEZUELA, AND NETHERLANDS ANTILLES.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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