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 Medizin Systeme Böblingen GmbH, has issued a medical device safety alert concerning its IntelliVue Patient Monitors MX400/450/500/550 [Model number: 866060, 866062, 866064, 866066] [HKMD No.: 140225, 140224].
The manufacturer modified the software configuration for the IntelliVue MX400/450/500/550 patient monitors. These changes were made to reflect some options becoming standard capabilities for software version N.x. In the process, the entitlements of software options M05, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities offered by software options M05, M06, and M20 when ordered/required by the customer.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 Jul 2024