Medical device recall lawyers at Pintas & Mullins Law Firm announce that GE Healthcare recently issued a recall of several Nuclear Medicine Imaging Systems. Unfortunately, the problem was brought to GE’s attention only after a patient died at a VA Medical Center.
The VA patient was fatally crushed by part of an Infinia Hawkeye 4 Nuclear Medicine System when it detached and fell on him during a scan. The 66-year-old victim was undergoing testing at the James J. Peters VA Medical Center in the Bronx borough of New York City. The Wall Street Journal reports that it was the gamma camera that collapsed and killed him.
A spokesperson for Peters Medical stated that the gamma camera was installed in 2006 and regularly maintained by GE. The Hawkeye System is one of the most popular systems on the market today and can weigh-in at more than 5,000 pounds. GE did not state whether there have been any additional incidents reported in other medical facilities.
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Gamma cameras, such as the one on the Hawkeye System, are typically used by nuclear-medicine physicians to scan organs, such as the lungs, and other tissue deep within the body. Physicians inject patients with radioactive fluids, which the gamma camera detects and tracks as it spreads throughout the anatomy. The scanning system can be used to enhance image quality in oncology, cardiology, neurology, and other diagnostic imaging applications.
Nearly every major hospital in the country has a gamma camera, consisting of large panels of crystal that convert radioactive rays into light. The camera itself takes digital pictures of that light, similar to a more traditional camera, as the panels rotate around the patient.
The machines have been used since the 1960s; other, newer models have recently been introduced by Siemens AG, Philips Electronics, and GE, and generally run between $300,000 and $800,000. Admittedly, patients are vulnerable during the scanning, as the system is insulated with thick layers of lead to help focus the gamma rays. The panels themselves weigh hundreds of pounds, however, fatal accidents such as this are unusual.
After inspecting the machine at the Peters VA Medical Center, GE stated that the bolts securing the camera to the gantry had come loose, which stressed the support mechanism and ultimately caused the camera to fall. The company subsequently issued two letters to hospitals regarding the systems. The first merely recommended that qualified maintenance personnel inspect the equipment, perform preventative procedures, and re-review system safety sections with the staff.
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The second letter was sent nearly a month later informing facilities of the recall, which encompasses not only the Hawkeye System but several other models as well because of the similarities in the support mechanism designs. The affected products include: the Brivio NM615, Discovery NM630, Discovery NM/CT670, Helix, Infinia, Optima NM/CT640, and VG and VG Hawkeye systems. All recalled models were distributed between October 1992 and June 2013.
Healthcare facilities with the recalled models are instructed to stop use of the systems until a GE Healthcare Field Engineer completes a full inspection of the system and performs necessary repairs. GE will contact all hospitals to arrange for the inspection, which will be provided free of charge. Any quality problems or injuries from the systems can be reported to the FDA’s MedWatch adverse event reporting program.
Dangerous medical device lawyers at Pintas & Mullins Law Firm will continue to report on recalls of defectively designed or manufactured products. If you or someone you love was seriously injured by a negligently-produced medical device, you may be entitled to compensation through a lawsuit against the manufacturer, and should contact a skilled personal injury attorney who can inform you of your legal rights.