FDA sends MRI recall notices to GE, Siemens

By AuntMinnie.com staff writers

March 26, 2015 -- The U.S. Food and Drug Administration (FDA) has sent recall letters to GE Healthcare and Siemens Healthcare regarding the operation of some MRI scanners.

The GE notice involves a potential safety issue with some 9,000 MRI systems in operation worldwide due to software that has not been maintained properly by the facilities.

GE spokesperson Amanda Gintoft said the recall involves service packs the company issues with all of its MRI scanners. The recall was done to ensure that all devices have the latest, most up-to-date software in place, based in part on the age and model of the system.

The fix can be done "in about five minutes" by a GE field engineer, she added. GE has also been able to check and update some of the MRI systems remotely.

"It has absolutely no impact on the use of the MRI," she said. "So customers do not have to stop using the system, and there is no impact in terms of efficiency or downtime."

According to Siemens' FDA notice, the company's Magnetom gradient output supervision was permanently turned off in some cases, which could lead to the gradient output exceeding its limits and causing peripheral nerve stimulation.

Siemens notified its customers of the issue on March 6. The FDA letter noted that 132 Siemens Magnetom scanners are affected by the recall. A Siemens' spokesman declined comment on the action.

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