Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Boston Scientific Zoom Latitude Programmer/Recorder/Monitor

27 Jun 2012

The Health Canada posted a medical device recall notice concerning Zoom Latitude Programmer/Recorder/Monitor, manufactured by Boston Scientific Corporation. The manufacturer found that some Model 3120 Programmers distributed in Canada are mislabeled. The affected Programmers do not included software to program Confient Implantable Cardioverter Defibrillator and Livian Cardiac Resynchronization Therapy-Defibrillator. The Software Models are Model 2888 and Model 2945 respectively for Confient and Livian. Model 3120 programmers with missing Model 2888 and 2945 software will not be able to interrogate or program Confient/Livian Defibrillators until the software has been loaded.

According to the local supplier, the affected products were not distributed in Hong Kong.

For details, please refer to the 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 affected product, please contact your supplier for necessary actions.

Posted on 27 June 2012

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