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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 p
Recalled September 23, 2015 · FDA recall Z-2784-2015 · St Jude Medical Cardiac Rhythm Management Division
Hazard
Some devices exhibit backup VVI operation due to a backup reset. · FDA Class II
Units
259,214 transmitters (U.S. distribution) 23,604 (foreign distribution)
Sold at
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, Saudi Arabia, Hungary, Switzerland.
Description
Some devices exhibit backup VVI operation due to a backup reset.
Product
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Manufacturer(s)
St Jude Medical Cardiac Rhythm Management Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →