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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 65096
Product Type Devices
Status Ongoing
Recalling Firm Boston Scientific CRM Corp
City Saint Paul
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including DC and PR

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. n/a Class II 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. 1 Z-1339-2013