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 Philips Azurion, Allura Xper, Integris and MultiDiagnost Eleva [System code: 722282, 722281, 722236, 722235, 722234, 722233, 722228, 722227, 722226, 722225, 722224, 722223, 722222, 722221, 722079, 722078, 722068, 722067, 722064, 722063, 722059, 722058, 722044, 722043, 722039, 722038, 722035, 722030, 722029, 722028, 722027, 722026, 722025, 722023, 722021, 722020, 722018, 722017, 722016, 722015, 722013, 722012, 722011, 722010, 722008, 722006, 722005, 722003, 722002, 722001, 708038, 708037, 708036, 708034, 708032][HKMD No.: 100205, 100206, 110046, 110047, 110048, 200480 and 230373].
The manufacturer has identified a potential safety issue with the Cable Hose Carriers of the Philips Azurion, Allura Xper, Integris and MultiDiagnost Eleva product families. It was identified that due to the forces applied when moving or turning the monitor of the system, the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may become loose and/or break. If this issue occurs, plastic parts and/or metal bolts of the Cable Hose Carrier(s) may fall and/or part of the cable hose may drop following the detachment of a Cable Hose Carrier.
According to the manufacturer, falling cable carrier parts and/or a drop of the cable hose may result in harm to an operator or a bystander in the vicinity (e.g., bruises/contusions, lacerations, pain, head injury, muscle/tendon damage, and neck stiffness).
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 Sep 2024