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 United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning GE Healthcare Service manuals for the CT, PET, or NM table [GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy; Affected system include Revolution EVO, Revolution Frontier, Discovery RT, Discovery MI, Discovery MI-DR, Discovery IQ] [HKMD No. of the affected system: 150352, 180540, 170059, 170137, 170263, 200090].
According to the FDA, as a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90368
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Aug 2022