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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
FAX
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
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