FDA-Device2015-09-23Class II
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
St Jude Medical Cardiac Rhythm Management Division
Hazard
Some devices exhibit backup VVI operation due to a backup reset.
Sold states
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.
Affected count
259,214 transmitters (U.S. distribution) 23,604 (foreign distribution)
Manufactured in
15900 Valley View Ct, Sylmar, CA, United States
Products
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2784-2015Don't want to check this manually?
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