Recall Z-2052-2011 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible
| Date | Apr 26, 2011 (initiated Jan 10, 2011) |
| Status | Terminated |
| Reason | Boston Scientific has determined that data within certain printed reports obtained from the LATITUDE Patient Management System may not be accurate, in that, the Most Recent Presenting Electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect. |
| Root cause | Software design |
| Action | Consignees were sent a Boston Scientific "LATITUDE Medical Records Information" letter dated January 2011. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also included the Rate of Occurrence, Action and Further Information sections. |
| Quantity | 25,836 |
| Distribution | Worldwide Distribution -- USA, including DC and PR, and countries of AUSTRALIA, CANADA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.