GE Healthcare takes nuclear imaging systems off line after unit collapses and kills patient

GE Healthcare's Infinia Hawkeye 4 system

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.

RSS From Medical Design & Outsourcing

  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
  • RIVANNA commences manufacturing of its Accuro device
    Rivanna Medical announced that it has begun manufacturing its FDA-cleared Accuro device, a handheld and untethered smart-phone-sized device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. The product will be launched at the ASA annual meeting in San […]
  • FDA seeks public input on Quality Metrics guidance
    by Oliver Wolf, Senior Product Manager, MasterControl In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation […]
  • First ‘Ear Wear’ for Active Adults Debuts with MDHearingAid FIT
    If you’ve burned out your ears with earbuds, headphones or decades of other audio abuse but aren’t ready for your grandmother’s hearing aids, not to worry! The new MDHearingAid FIT gets you back in the game with a tiny, FDA-registered, one-size-fits-most solution that doesn’t block your ear canal like old-fashioned in-the-ear hearing aids. The FIT feels […]
  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
    CardioGenics Holdings, developer for the In-Vitro-Diagnostics (“IVD”) testing market, announced that it has entered into a manufacturing agreement with Plasticap of Ontario, Canada, pursuant to which Plasticap will manufacture CardioGenics’ proprietary self-metering cartridges for its QL Care analyzer. The term of the agreement is three years and the purchase price for each cartridge shall be […]
  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]

Leave a Reply