Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning R GE Healthcare Nuclear Medicine 600/800 Series systems [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.] [HKMD No.: 190336, 190004, 190296, 190377, 200051, 200050].
According to TGA, for certain Nuclear Medicine systems, the manufacturer 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.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01561-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Dec 2022