The Therapeutic Goods Administration (TGA), Australia's regulatory authority for therapeutic goods, has informed the health professionals and consumers that GE Healthcare, in consultation with the TGA, has initiated a recall for product correction for a number of its nuclear medicine imaging systems.
Nuclear medicine imaging systems are used to take images of parts of the body to diagnose a variety of diseases.
GE Healthcare has advised hospitals and radiology clinics that have the affected nuclear medicine imaging system to stop using the machine until it can be inspected by a GE technician.
This action has been taken in response to an incident in the United States, in which a patient died due to injuries sustained when a portion of an Infinia Hawkeye 4 nuclear medicine imaging system fell onto them during a scan. It has been identified that the bolts securing the camera to the gantry were loose, resulting in stresses on the imaging system support mechanism.
Due to similarities in the design of many of GE Healthcare’s nuclear medicine imaging systems, this recall action affects all models of the systems: Infinia Nuclear Medicine systems; VG and VG Hawkeye Nuclear Medicine systems; Helix nuclear medicine systems; Brivo systems; Discovery systems; Optima systems; Information for consumers.
GE Healthcare has contacted all hospitals and clinics that have one of the affected nuclear medicine imaging systems and has advised them to stop using the system until it can be inspected.
Due to the prevalence of affected nuclear medicine imaging systems in Australia and the need to have such systems inspected regarding this issue before use, there may be delays in accessing some diagnostic scan services.
Consumers and health professionals are encouraged to report problems with medical devices. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).