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MRI Systems Recalled Over Connection Issues

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MRI Systems Recalled Over Connection Issues

MRI Systems Recalled Over Connection Issues

A Class I recall has been issued for almost 13,000 General Electric MRI systems due to a potentially life-threatening technical problem.

The recall affects more than 12,968 MRI systems and numerous brands, including Signa and Discovery. The recall includes 5,708 devices in the United States and 7,260 in other countries. The U.S. Food and Drug Administration (FDA) said in a February 18 Class I recall notice that “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries.” A Class I recall indicates that the affected device has the potential to cause serious injury or death. It is the FDA’s most serious recall designation.

GE Healthcare sent customers, including hospital administrators/risk managers, radiology department managers and radiologists, an “Urgent Medical Device Correction” letter on January 6 informing them of a specific 4-step preventative test designed to check the MRU connection. If a device is not working properly, customers are instructed to stop using it.

According to the notice, the problem is caused by poor training or employee error. “Some MR systems in India had been modified to disable the magnet rundown unit,” a GE spokeswoman told ModernHealthcare.com.

A full list of the affected devices can be viewed here.

breakinglawsuitnews.com disclaimer: This article: MRI Systems Recalled Over Connection Issues was posted on Monday, February 23rd, 2015 at 4:20 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits, Other Lawsuits.

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