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Recall Observatory FDA recall evidence

Device product

Merlin PCS programmer (Model # 3650), Software (Model # 3330)

Z-2329-2018

April 16, 2018

Class II

Product summary

Firm
St Jude Medical Inc.
Event
Event 80212
Status
Terminated
Classification
Class II
Quantity
71651
Official record key
device-enforcement:Z-2329-2018

Official wording

Reason: 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.

Code information: Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada)

Distribution pattern: U.S. Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.