GE MRI Safety Recall
01 April 2015

General Electric has announced a recall that may include your GE MR system.  Please see the recall below and the FDA recommended action.

Manufacturer Reason
for Recall

GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.

FDA Determined
Cause 2

PRODUCTION CONTROLS: Software Manufacturing/Software Deployment  

Action

General Electric has issued an Urgent Medical Device Correction dated March 9, 2015.

GE Healthcare has become aware of a potential safety issue due to software versions not being maintained properly at some sites after service activities were performed that required software to be reloaded. The most recently deployed on-site software version may include safety updates.

OI Healthcare is inspecting all affected systems and will ensure the proper software version is installed.

OI Healthcare representative will notify you if a correction is needed.


 

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