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 issued a medical device safety alert concerning its IntelliSpace Cardiovascular [Reference Number: 830089; Lot Number (Software Version) 7.0.0.0][HKMD No.: 200400].
The manufacturer has identified the following issue with IntelliSpace Cardiovascular (ISCV) software version 7.0: When the field “Reason for Study” in the application is populated (via HL7 or manually) into ISCV with more than 64 characters, the study data cannot be archived, exported, or copied from ISCV via DICOM or to a CD, but the images are available on the ISCV database and are accessible to every authorized user within the application.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 Apr 2024