FDA regulators put their highest-risk label on GE Healthcare’s (NYSE:GE) recall of its Infinia Hawkeye 4 system after a unit collapsed and killed a patient in a New York Veterans Administration hospital last month.
The federal watchdog agency branded the recall ‘Class I’, a label reserved for device malfunctions or issues that may cause serious injury or death.
The warnings came after a 66-year old patient was killed at a Veterans Administration hospital after being crushed by part of the Infinia Hawkeye 4 system during a scan. The Infinia Hawkeye 4 is one of the largest devices of its kind and can weigh more than 5,000 pounds.
The falling risk, attributed to loose bolts securing the system’s camera to its gantry, is considered very rare, but GE nonetheless took the systems off-line until they can be inspected by company officials.
The FDA recommended no actions beyond what GE had already advised.
"GEHC is dedicating resources to these activities so that the global installed base inspection activities can be completed appropriately and as quickly as possible,"GE Healthcare spokesman Benjamin Fox told MassDevice.com earlier this month.
Healthcare agencies around the world issued warnings to their own healthcare systems, including the Hong Kong Dept. of Health, Australia’s Dept. of Health & Ageing and the U.K.’s Medicines & Healthcare Products Regulatory Agency.
