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 Philips Medical Systems Nederland B.V. Ingenia Ambition X and Ingenia Ambition S [Product code: 781356, 781359] [HKMD numbers: 200408].
According to the FDA, the sealed magnet will experience uncontrolled shutdown known as Loss-of-Field if the magnet loses cryo-cooling (e.g. caused by a power outage on site).
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93739
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Jan 2024