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 SIEMENS systems Luminos Agile Max, Luminos dRF Max, LUMINOS Lotus Max with display ceiling suspension and Multitom Rax with display wall suspension [HKMD No.: 120150, 130099, 160231, 240007].
According to the MHRA, there is a potential risk that the mounting screw on the support of the display ceiling/wall suspension may loosen or be missing, causing the support arm with displays to lower downwards with continued use. In a worst-case scenario, the support arm could lower suddenly and cause serious injury.
For further information, please visit: https://mhra-gov.filecamp.com/s/d/wvxvTxnVNNT7Ylv2
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Jul 2024