03.12.15
GE Healthcare has warned customers about a safety issue involving MRI machines manufactured over nearly 30 years after a single human error incident in India revealed that a key safety function can be disabled.
According to the U.S. Food and Drug Administration (FDA), two hospital employees who entered an MRI (magnetic resonance imaging) room carrying a metal container have been injured due to these machines. The recall, affecting MRI machines manufactured and distributed between 1985 and December 2014, has been labeled a Class 1 -- the most serious designation, as it could lead to serious injury or death.
GE Healthcare warns that service personnel may have modified the affected MRI machines to disable the magnet rundown unit, which helps shut down the magnetic field in emergencies. In early January, GE Healthcare's urgent medical device correction walked customers through confirming that the magnetic rundown unit properly is connected to the magnet. In a Feb. 20 follow-up notice, GE Healthcare noted that the original FDA notice was "not related to any manufacturing defect or product-related error. It was a case of human error on site, and is in response to a single safety incident in India." The company claims the warnings were issued to "ensure this human error was not occurring at other sites globally."
GE Healthcare advises its MRI customers to perform a five-minute check to ensure the magnetic rundown unit (an "emergency off switch" for the magnet) remains connected. Once technicians confirm the magnetic rundown unit is connected and functioning (a process that should be conducted weekly), the MRI system can be used as normal. "It is a common industry practice to have an 'emergency off switch' for the magnet, which should be checked regularly," the follow-up warning states. "GE Healthcare is following up with all customers and will correct affected systems at no cost to customers."
GE Healthcare develops medical imaging, software and information technology, patient monitoring and diagnostics, drug discovery and biopharmaceutical manufacturing technologies, and performance improvement solutions.
According to the U.S. Food and Drug Administration (FDA), two hospital employees who entered an MRI (magnetic resonance imaging) room carrying a metal container have been injured due to these machines. The recall, affecting MRI machines manufactured and distributed between 1985 and December 2014, has been labeled a Class 1 -- the most serious designation, as it could lead to serious injury or death.
GE Healthcare warns that service personnel may have modified the affected MRI machines to disable the magnet rundown unit, which helps shut down the magnetic field in emergencies. In early January, GE Healthcare's urgent medical device correction walked customers through confirming that the magnetic rundown unit properly is connected to the magnet. In a Feb. 20 follow-up notice, GE Healthcare noted that the original FDA notice was "not related to any manufacturing defect or product-related error. It was a case of human error on site, and is in response to a single safety incident in India." The company claims the warnings were issued to "ensure this human error was not occurring at other sites globally."
GE Healthcare advises its MRI customers to perform a five-minute check to ensure the magnetic rundown unit (an "emergency off switch" for the magnet) remains connected. Once technicians confirm the magnetic rundown unit is connected and functioning (a process that should be conducted weekly), the MRI system can be used as normal. "It is a common industry practice to have an 'emergency off switch' for the magnet, which should be checked regularly," the follow-up warning states. "GE Healthcare is following up with all customers and will correct affected systems at no cost to customers."
GE Healthcare develops medical imaging, software and information technology, patient monitoring and diagnostics, drug discovery and biopharmaceutical manufacturing technologies, and performance improvement solutions.