Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software,

FDA device recall Z-2052-2011 · posted 2011-04-26 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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.

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.

Root cause

Software design

Status

Terminated

Product code

LWS

Quantity affected

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, SWEDE

Date initiated

2011-01-10

Date posted

2011-04-26

Date terminated

2012-11-15

Location

Saint Paul, MN