FDA-Device2015-01-21Class II
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
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.
Sold states
Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).
Affected count
257,456 units
Manufactured in
15900 Valley View Ct, Sylmar, CA, United States
Products
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2015Don't want to check this manually?
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