The Therapeutic Goods Administration (TGA), Australia issued a medical device safety alert concerning Discovery 670, Optima 640, Discovery NM630 and Brivo NM615 (all configurations), manufactured by GE Healthcare.
Contact between the detector and the patient's elbow may occur during single-photon emission computed tomography protocols using 45 degree angular steps in scenarios when a patient's arms are positioned above the head and when dedicated safety armbands are not utilised.
GE Healthcare advises users to ensure the patient and the patient's extremities are not protruding beyond the table limits. If the patient's arms need to be extended above their head, users are advised to use the armbands provided. A software update will be provided by the manufacturer.
For details, please refer to TGA website:
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 October 2013