Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: St.Jude Medical Merlin@Home Transmitter

27 Jun 2012

The Health Canada posted a medical device recall notice concerning Merlin@Home Transmitter, manufactured by St. Jude Medical, Cardiac Rhythm Management System. The affected model number is EX1150.

According to the manufacturer, there is potential for intermittent communication difficulties with these Merlin@Home Transmitters due to an anomaly with a microcontroller chip in the transmitter. If the anomaly occurs, the patient's Merlin@Home Transmitter will not be able to send data to the Merlin.net database. However, implanted device function is not affected.

For details, please refer to Health Canada website
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.php

If you are in possession of the product, please contact your supplier for necessary actions.

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