St Jude Medical Cardiac Rhythm Management Division recalls Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pac…

Recall date

August 18, 2015

Source

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

Recall number

Z-2784-2015

FDA classification

Class II

Brand / firm

St Jude Medical Cardiac Rhythm Management Division

Sold / distributed

Worldwide Distribution-US (nationwide) and foreign distribution to the following: Japan, France, Austria, Canada, Italy, Spain, Netherlands, South Africa, Great Britain, Australia, Sweden, Belgium, Finland, Germany, Portugal, Singapore, Norway, Poland, Ireland, Czech Republic. Denmark, Hong Kong, S…

Why it was recalled

Some devices exhibit backup VVI operation due to a backup reset.

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. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.