GE Healthcare (NYSE:GE) issued an urgent field safety notice on its nuclear medicine systems after part of an Infinia Hawkeye 4 system collapsed and killed a patient in a New York Veterans Administration hospital.
Last month a 66-year-old patient was crushed by the Infinia system, a gamma camera, while undergoing a procedure. The Infinia Hawkeye 4 is one of the largest devices of its kind and can weigh more than 5,000 pounds, according to the Wall Street Journal. The Journal last month reported on the death, which occurred at James J Peters VA Medical Center.
Experts said the accident was extremely rare, but GE Healthcare nonetheless issued a wide-scale warning, asking healthcare providers cease use of a series of nuclear medicine systems while the company comes around to conduct inspections.
The death occurred on June 5, GE Healthcare spokesman Benjamin Fox confirmed with MassDevice.com today. GE was granted access to the Infinia Hawkeye 4 machine on June 17 and determined that it had collapsed due to loose bolts securing the camera to the gantry.
GE issued a letter June 13 recommending that hospitals ensure that their equipment undergo recommended maintenance from qualified service personnel. On July 4 the healthcare giant issued an updated letter recommending that all sites stop using their nuclear imaging systems until GE can conduct an inspection.
Due to "similarities in the design of the support mechanisms across many products, the recommendation was not isolated to the Infinia Hawkeye 4 but also includes all Infinia and Infinia Hawkeye systems, all VG and VG Hawkeye systems and all Helix systems. In the latest letter, GE added that all Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems to the advisory.
"GEHC is dedicating resources to these activities so that the global installed base inspection activities can be completed appropriately and as quickly as possible," Fox told us.
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.