Recall Z-0032-2018— St Jude Medical Inc.
Class II · Terminated
Class II FDA medical device recall by St Jude Medical Inc., initiated 2017-08-28, terminated 2020-07-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications..
- Recalling firm
- St Jude Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-28
- Terminated
- 2020-07-08
- Firm location
- Sylmar, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.