Z-1096-2012

LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely...

Name: Z-1096-2012 LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely...
Creator: Boston Scientific CRM Corp
Published: 2011-12-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-12-19 / Terminated / root cause: software

FDA source

Boston Scientific CRM Corp began a recall of LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse... on 2011-12-19. The reason FDA records is "Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with...". 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-1096-2012
Status: Terminated
Initiated: 2011-12-19
Posted: 2012-02-23
Terminated: 2012-10-25
Recalling firm: Boston Scientific Corporation
Product: LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated 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 is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.
Root cause tag: software
FDA root cause: Software design
Action: Beginning on December 19, 2011, for the patients that have attempted to set-up their communicators, Boston Scientific called the patients and their associated LATITUDE clinics to let them know that they can now complete the set-up.
Quantity in commerce: 1
Distribution: Nationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA.
Product codes and lots: Software version 7.2

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)