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 Wired Avalon Ultrasound Transducer [Product number: 867246; Software version: L.01.04] [HKMD No.: 210305].
According to the manufacturer, it was found that the latest version of the wired Avalon Ultrasound Transducers (867246) may report inaccurate Fetal Heart Rate (FHR) measurements when monitoring multiples (twins or triplets): In situations where the physiological signal (echo from the fetal heart) is absent or very weak (e.g. in early weeks of pregnancy), there is a tendency of the wired Ultrasound transducers to interfere with each other and subsequently to produce an artificial FHR, mostly at approximately 180 bpm. The use cases affected by this issue are twin or triplet monitoring with wired Ultrasound Transducers including at least one transducer with software version L.01.04. The population at risk is women with multiple gestation (twins/triplets).
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 May 2024