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 Centricity PACS-IW with Universal Viewer, Centricity Universal Viewer and Centricity PACS-IW [HKMD No.: 120224].
According to the FDA, the manufacturer has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92062
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 May 2023