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 Medical Systems Information Technologies Prucka 3 Amplifiers used with CardioLab / ComboLab systems [HKMD number: 230058].
According to the FDA, capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94717
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 Jul 2024