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 Siemens Medical Solutions USA, Inc Luminos Agile Max (VF10, VF11), Luminos dRF Max (VF10, VF11), LUMINOS Lotus Max (VF11) [Model: 10762472, 10762471, 11574100] [HKMD No.: 120150, 130099].
According to the FDA, under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92229
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 May 2023