Company: Boston Scientific CRM Corp
Date of Enforcement Report 6/15/2011
Class ll:
PRODUCT
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. Recall # Z-2052-2011
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.
RECALLING FIRM/MANUFACTURER
Boston Scientific CRM Corp., Saint Paul, MN, by letter dated January 2011. Firm imitated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
25,836 units
DISTRIBUTION
Nationwide and Internationally
