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.
Authorities have posted several medical device safety alerts concerning GE Medical Systems Information Technologies Inc. Prucka 3 Amplifiers, Field Replaceable Units (FRUs) used with CardioLab AltiX and ComboLab AltiX [Model or catalog number: 2300000-005, P1801PA, 5875569; GTIN 00195278507044 (CardioLab) and 00195278507051 (ComboLab); Multiple Lot or Serial numbers] [HKMD No.: 100130].
According to authorities, the manufacturer has become aware that a diode on the power supply of the Prucka 3 Amplifier used with cardiolab/combolab systems could reach elevated temperatures. This could cause the amplifier to fail and consequently power off and become inoperable.
For further information, please visit
Health Canada: https://recalls-rappels.canada.ca/en/alert-recall/combolab-altix
The United States Food and Drug Administration (FDA): https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92903
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Aug 2023
Updated on 21 Sep 2023