FDA Device recall Z-0032-2018
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable…
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable… by St Jude Medical, citing new pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0032-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-28 |
| Published | 2017-10-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | n/a |
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.
Identifiers
| code_info | Software version 23.1.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0032-2018%22
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