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 Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Siemens Healthcare GmbH ARTIS pheno, ARTIS icono biplane and ARTIS icono floor with VE OR Table [HKMD No.: 180011, 210368].
According to the MHRA, during transversal table movement, it could happen that the rolling bearing may get dislocated; it is part of the linear guide rail and enables the transversal table movement. As a consequence of this unlikely event the rolling bearing may fall out of the linear guide rail. As a further consequence the mechanical connection between table top and table base may get lost.
In the very unlikely case of occurrence, it cannot be excluded that the patient may fall off the table and the patient and/or the user may be injured. This may result in a situation where it may be necessary to cancel clinical treatment or to continue treatment on an alternative system.
For further information, please visit https://mhra-gov.filecamp.com/s/d/AXdEvOwjPJJPEmcK
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Dec 2023