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GE Healthcare Nuclear Medicine Systems: Class I Recall

GE Healthcare has issued a recall for several Nuclear Medicine Imaging Systems because of the possibility of serious injuries or death due to the failure mode associated with this recall. GE Healthcare became aware of an incident at the VA Medical Center facility in the U.S. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. These Nuclear Medicine systems are used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient’s body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. Products affected by the recall include: Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine Systems, Helix Nuclear Medicine Systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670. Healthcare facilities are instructed to immediately stop using their Nuclear Medicine system until a GE Healthcare Field Engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost. Healthcare patients and professionals should report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. For more information on the program, go to www.fda.gov/MedWatch/report.htm If you or a loved one has been seriously injured as a result of this recalled medical device or any other device, contact Finkelstein & Partners immediately. Read the full recall report here: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362963.htm