FDA designates GE imaging device recall "Class I" after fatal accident

07/31/2013 | MassDevice.com (Boston)

The FDA has designated the recall of GE Healthcare's nuclear imaging systems "Class I" after the company's Infinia Hawkeye 4 collapsed on a patient during an imaging procedure, killing him. The alert is issued when the use of a device may lead to serious health consequences or death. "GEHC is dedicating resources to these activities so that the global installed base inspection activities can be completed appropriately and as quickly as possible," said GE Healthcare spokesman Benjamin Fox.

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MassDevice.com (Boston)

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