On March 20th, the FDA posted two separate Class 2 recalls, one concerning 9,369 GE MRI systems and another concerning 132 Siemens MAGNETOM MRI systems.

The GE notice cites the manufacturer reason for recall as follows, "GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites."

GE sent an "Urgent Medical Device Correction" letter dated March 9, 2015, to all affected customers, (6,432 of whom are outside of the U.S.). The letter described the safety issue, safety instructions, affected product details, product correction and contact information.
"This is a 5-minute, free, double-check of the software version on the MRI system, performed by a GE Field Engineer. It's similar to checking for an iPhone software update. There is no impact on usage of the MRI," said Amanda Gintoft, PR manager for GE Healthcare, in an e-mail to DOTmed News.

For GE, this is the second MRI recall of the year.

The FDA notice for Siemens MRI systems cites the manufacturer reason for recall as, "The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur."

A Customer Safety Advisory Notice, dated March 6, 2015, was sent to end users to inform them of the potential issue and what measures were being taken to mitigate possible risks, according to the FDA.

When contacted by DOTmed News via e-mail, Siemens declined to comment.

A Class 2 recall, as defined by the FDA, pertains to products that might cause a temporary health problem, or pose only a slight threat of a serious nature. They are less critical than Class 1 recalls.

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