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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-01561-1
Product Name/Description	Nuclear Medicine 600/800 series systems Nuclear Medicine 600/800 Series systems affected: Brivo 615, Discovery NM 630, Optima 640, Discovery NM/CT 670 DR, Discovery NM/CT 670 ES, Discovery NM/CT 670 Pro, Discovery NM/CT 670 CZT, NM 830, NM 830 ES, NM/CT 850, NM/CT 850 ES, NM/CT 860, NM/CT 860 ES, NM/CT 870 CZT, NM/CT 870 DR, NM/CT 870 ES. Multiple Serial Numbers. ARTG 156649 & 156650
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	20/12/2022
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	For certain Nuclear Medicine systems GE Healthcare has become aware that a safety mitigation may not be correctly implemented. If this is the case, the detector may fall leading to life-threatening bodily injury. There have been no injuries reported as a result of this issue.
Recall Action	Product Defect Correction
Recall Action Instructions	GE Healthcare asks that customers STOP USE of impacted Nuclear Medicine systems, until an inspection of each system is completed by GE Healthcare. A GE Healthcare representative will contact impacted customers to arrange for this correction. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	1-800-659-465 - GE Healthcare Service