Device 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.
Z-0032-2018
Product summary
- Event
- Event 78093
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,453 units
- Official record key
device-enforcement:Z-0032-2018
Official wording
Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Code information: Software version 23.1.1
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.