MARCH 2015 Vol. 4, Issue 1


HT TOPIC

FDA CLASS 1 DEVICE RECALLS

Please be aware that GE and Alltech superconductive systems are cited in FDA Class 1 device recalls issued Feb 18 2015, regarding Quench button (MRU or magnet rundown units) following information that the MRU had been disconnected at some sites in India.

A matching recall has been issued regarding particular Alltech MR systems.

The systems covered by the recall are installed globally. Contact your local supplier for individual details on how to respond.

Links to the FDA notices

GE: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132519

Alltech Echostar: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132519

 

 

E-Signals is a publication by the International Society for Magnetic Resonance in Medicine for the benefit of the SMRT membership and those individuals and organizations that support the educational programs and professional advancement of the SMRT and its members. This publication is the compilation of the leadership of the SMRT and the contributions of the staff in the ISMRM Central Office.