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St Jude Medical Cardiac Rhythm Management Division recalls Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Trans
Recalled January 21, 2015 · FDA recall Z-0949-2015 · St Jude Medical Cardiac Rhythm Management Division
Hazard
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers. · FDA Class II
Units
257,456 units
Sold at
Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).
Description
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
Product
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Manufacturer(s)
St Jude Medical Cardiac Rhythm Management Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →