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.
Medical device manufacturer, Philips Medical Systems Nederland B.V., has posted a medical device safety alert concerning its Ingenia Ambition X [Product Number (REF): 781356, 782109] and Ingenia Ambition S MR systems [Product Number (REF): 781359] [HKMD No.: 200408].
According to the manufacturer, an issue has been identified in the Philips Ingenia Ambition X and Ingenia Ambition S MR systems that could pose a risk for service personnel or other persons nearby the magnet during magnet decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet. In the initial design of the hoisting blocks, the diameter to meet the required bolt-on interface surface for the swivel eye bolts, used as lifting hardware, did not meet the required specification.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 Sep 2023