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 Boston Scientific pulse generator and transfer data to a central database.
This recall has been terminated (originally issued April 26, 2011).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- January 10, 2011
- Posted
- April 26, 2011
- Terminated
- November 15, 2012
- Recall Number
- Z-2052-2011
- Quantity
- 25,836
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
Software Versions 6.x versions launched on June 6, 2010 or later.
Root Cause
Software design
Action Taken
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.