Recall Z-0333-2012 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
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 an
| Date | Dec 1, 2011 (initiated Oct 12, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| 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. |
| Quantity | 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, SWEDEN, SWITZERLAND, UNITED KINGDOM, CANADA, AUSTRALIA, NEW ZEALAND, CYPRUS, CZECH REPUBLIC, GREECE, GU |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.