LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the pro

FDA device recall Z-0333-2012 · posted 2011-12-01 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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

Action taken

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

Status

Terminated

Product code

LWS

Quantity affected

25,300 (14,700 US; 10,600 OUS)

Distribution

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, SWE

Date initiated

2011-10-12

Date posted

2011-12-01

Date terminated

2012-12-04

Location

Saint Paul, MN