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 Transmi…

Recall date

December 18, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0949-2015

FDA classification

Class II

Brand / firm

St Jude Medical Cardiac Rhythm Management Division

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter