FDAFDA · Food and drugs·Recall number 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, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
Published October 25, 2017 · Recall initiated: August 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical Inc.
- Distributor
- Worldwide Distribution
- Lot
- Software version 23.1.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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