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Recall Observatory FDA recall evidence

Device product

LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

Z-1339-2013

April 10, 2013

Class II

Product summary

Firm
Boston Scientific CRM Corp
Event
Event 65096
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1339-2013

Official wording

Reason: Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.

Code information: n/a

Distribution pattern: Nationwide Distribution including DC and PR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.