Home / Recalls / Boston Scientific CRM Corp / Z-1339-2013

Z-1339-2013 Class II Terminated

Recalled by Boston Scientific CRM Corp — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
May 29, 2013
Initiation Date
April 10, 2013
Termination Date
November 26, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution including DC and PR

Code Information

n/a

Other recalls by Boston Scientific CRM Corp

  • Z-0088-2015 Class II — Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, (September 17, 2014)
  • Z-0087-2015 Class II — Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, (September 17, 2014)
  • Z-2147-2014 Class II — Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models (June 19, 2014)
  • Z-0026-2014 Class II — Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, (August 29, 2013)
  • Z-0025-2014 Class II — Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, (August 29, 2013)
  • Z-1979-2013 Class II — Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Card (July 15, 2013)
  • Z-0965-2013 Class II — Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. (March 1, 2013)