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St Jude Medical Inc. Recall: Merlin PCS programmer (Model # 3650), Software (Model # 3330)

St Jude Medical Inc. Recall: Merlin PCS programmer (Model # 3650), Software (Model # 3330) is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: St Jude Medical Inc.; Product: Merlin PCS programmer (Model # 3650), Software (Model # 3330); Reason for recall: The firm is releasing new firmware

Recalling firmSt Jude Medical Inc.
ProductMerlin PCS programmer (Model # 3650), Software (Model # 3330)
Reason for recallThe 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionU.S. Nationwide distribution
Recall initiated20180416
Recall numberZ-2329-2018
Categorydevice
StateCA
CountryUnited States

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