Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Alltech Medical Systems America Echostar Spica 1.5T MRI system

27 Feb 2015

The United States Food and Drug Administration (FDA) posted a medical device safety alert concerning Echostar Spica 1.5T MRI system [Serial Number: D-ESP-1001 and D-ESP-1003] manufactured by Alltech Medical Systems America.

The manufacturer is initiating a voluntary recall as the MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

For details, please refer to the following link:

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=70238&w=02252015%E2%8C%A9=eng

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

Posted on 27 February 2015

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