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 Medizin Systeme Böblingen GmbH (Philips North America LLC) IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 [HKMD No.: 140224, 140225].
According to the FDA, devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95324
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 07 Oct 2024