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 (Cleveland) Inc, has issued a medical device safety alert concerning its Pinnacle3 Radiation Therapy Planning System [Software Version: 16.2, 16.2.1, 16.4, 16.4.1, 16.4.3, 16.4.6, 18.0.1] [HKMD No.: 200244].
According to the manufacturer, Philips has identified that the Instructions for Use (IFU) for the Pinnacle3 Radiation Therapy Planning Systems may contain incorrect addresses for the Manufacturer, EU Representative, EU Importers, and/or Australian Sponsor.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Jul 2024