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U.S. Department of Health and Human Services

Class 2 Device Recall Merlin Patient Care System

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  Class 2 Device Recall Merlin Patient Care System see related information
Date Initiated by Firm August 28, 2017
Create Date June 12, 2018
Recall Status1 Open3, Classified
Recall Number Z-0032-2018
Recall Event ID 78093
PMA Number P030054S135 P030054S329 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1
The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
Code Information Software version 23.1.1
Recalling Firm/
Manufacturer
St Jude Medical Inc.
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Candace Steele Flippin
651-756-6293
Manufacturer Reason
for Recall
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774.
Quantity in Commerce 10,453 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NIK and Original Applicant = St. Jude Medical
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