Safety warning for medical devices of the manufacturer SEBBIN
The Federal Office for Safety in Health Care (BASG) has been informed that the manufacturer SEBBIN, which went bankrupt in March 2025, has no legal successor who continues to fulfil the manufacturer obligations arising from the Regulation (EU) 2017/745 on medical devices („MDR“), as amended. These obligations include Post Market Surveillance (PMS), which contains the investigation of incidents and, where appropriate, the initiation of field safety corrective actions.
Since the bankruptcy of the manufacturer in March 2025, SEBBIN´s medical devices on the market are no longer monitored for their safety and effectiveness by the manufacturer. There is also no successor in title who fulfils these tasks.
The BASG recommends increased safety awareness for the continued use of already purchased medical devices. The attending physician or the operator of the health care facility should use a risk-benefit assessment to determine whether further use of these already purchased medical devices in their health care facility is indicated in the interest of the patients. The BASG draws attention to the need for more intensive monitoring of the functionality of these medical devices.
According to the information available to the BASG, this affects the entire product range of the manufacturer SEBBIN.
Furthermore, we would like to remind you of the reporting obligation. According to § 40 Medical Devices Act 2021 (MPG 2021), BGBl. I Nr. 122/2021, any incident that could lead to serious deterioration of state of health or death of a patient, user or third party must be reported immediately to the Federal Office for Safety in Health Care.
The registration forms can be found online at: https://www.basg.gv.at/en/market-surveillance/reporting/medical-devices-vigilance#c22082
