Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Published July 4, 2018 · Recall initiated: April 16, 2018
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
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical Inc.
- Distributor
- U.S. Nationwide distribution
- Lot
- Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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