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Terminated

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.

FDA Recall Z-1096-2012 · Posted 2012-02-23

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWS
Date Initiated2011-12-19
Date Terminated2012-10-25
Product Quantity1

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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