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 Philips Medical Systems Nederland B.V. Azurion Systems [Azurion 3 (Model: 722221, 722222, 722280); Azurion 5 (Model: 722227, 722228); Azurion 7 (Model: 722223, 722224, 722225, 722226)] [HKMD number: 230373].
According to the MHRA, the manufacturer has become aware of a potential safety issue for a limited number of Azurion Systems which may experience a power disruption resulting in the device being unavailable for use. The Philips Azurion System contains a Certeray generator that may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss. In this case the source of electrical current will stop, preventing further damage. Prior to fuses tripping, users may experience a burning smell coming from the generator. A power disruption resulting from a short circuit in the Certeray generator may occur during installation or during clinical use. If this issue occurs during clinical use, it may cause a loss of power, resulting in a potential delay of procedure or termination of procedure.
For further information, please visit https://mhra-gov.filecamp.com/s/d/1S39hkEkWAN6TjXE
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Feb 2024