FDA recall Z-0032-2018

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 for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2017-08-28

Report date

2017-10-25

Termination date

2020-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sylmar, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0032-2018