Z-2052-2011

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

Name: Z-2052-2011 Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server...
Creator: Boston Scientific CRM Corp
Published: 2011-01-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-01-10 / Terminated / root cause: software

FDA source

Boston Scientific CRM Corp began a recall of Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server... on 2011-01-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2052-2011
Status: Terminated
Initiated: 2011-01-10
Posted: 2011-04-26
Terminated: 2012-11-15
Recalling firm: Boston Scientific Corporation
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.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: Software Versions 6.x versions launched on June 6, 2010 or later.

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)