Recall Z-0032-2018 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
St Jude Medical Inc.
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.
| Date | Aug 28, 2017 |
| Status | Terminated |
| Reason | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. |
| Root cause | 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 | 10,453 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.