Date Initiated by Firm | August 28, 2017 |
Create Date | June 12, 2018 |
Recall Status1 |
Terminated 3 on July 08, 2020 |
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
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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
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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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = NIK
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