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St Jude Medical Inc. recalls Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Recalled July 4, 2018 · FDA recall Z-2329-2018 · St Jude Medical
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. · FDA Class II
Units
71651
Sold at
U.S. Nationwide distribution
Description
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.
Product
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Manufacturer(s)
St Jude Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →