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Potentially life-threatening issue prompts recall of 12,000-plus MRI devices
Modern Healthcare

The FDA has issued a Class I recall on more than 12,000 General Electric MRI systems because of a potentially life-threatening, nonfunctioning part of the devices. Class I is the FDA’s most serious designation for recalls, indicating severe injury or death could occur as the result of issues with a product. The recall covers numerous GE MRI brands, including Signa and Discovery. The 12,968 devices affected by the recall include 5,708 in the U.S. and 7,260 in other countries. GE had discovered that the magnet rundown units on its imaging devices may not be properly connected.