Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01062-1
Product Name/Description Discovery NM/CT 670, Optima NM/CT 640, Discovery NM630 and Brivo NM615 (all configurations) (Nuclear Medicine System)

ARTG Number: 200439
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/10/2013
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue Contact between the Detector and the Patient's elbow may occur during SPECT 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.
Recall Action Recall for Product Correction
Recall Action Instructions GE Healthcare is advising users to ensure the patient and the patient's extremities are not protruding beyond the table limits. GE is advising that if the patient's arms need to be extended above their head, to use the provided armbands. A software update will be provided by GE by February 2014.
Contact Information 1800 659 465 - GE Healthcare National Call Centre