Home / Recalls / Medical Devices
St Jude Medical Inc. recalls Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Prog
Recalled October 25, 2017 · FDA recall Z-0032-2018 · St Jude Medical
Hazard
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. · FDA Class II
Units
10,453 units
Sold at
Worldwide Distribution
Description
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
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.
Manufacturer(s)
St Jude Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →