Safety warning for medical devices of the manufacturer LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H.
The Federal Office for Safety in Health Care (BASG) has been informed that the "LOGIMED Medizinische Spezialprodukte Gesellschaftm.b.H., Gösserstraße 11, 8700 Leoben" (Fa.Logimed), which was liquidated in 2011, has no legal successor who continues to fulfil the manufacturer obligations arising from the Medical Devices Act (MPG). These obligations include Post Market Surveilance System (PMS), which includes the investigation of incidents and, where appropriate, the initiation of security corrective actions in the field.
Since the liquidation of the manufacturer in 2011, Logimed's medical devices on the market are no longer monitored for their safety and efficacy by the manufacturer. There is also no successor in title who fulfils these tasks.
The Federal Office 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 the patient's own home is indicated in the interest of the patients.The Federal Office draws attention to the need for more intensive monitoring of the functionality of these medical devices.
The BASG does not have a list of medical devices placed on the market by Logimed that are still in use or are kept ready for use. According to the information available to the Federal Office, Logimed has placed the following types of products on the market:
- Drill, orthopaedic (17-995)
- Prosthesis, femoral head (16-125)
- Prosthesis, joint, hip, acetabulum component (16-084)
- Prosthetic Implantation Instrument (17-993)
- Screw, bone (16-101)
Furthermore, we would like to remind you once again of the reporting obligation. According to § 70 MPG, any incident that could lead to a serious impairment 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: www.basg.gv.at/medizinprodukte/formulare/mp-zwischenfall/
|Medical devices||Bohrer, orthopädisch (17-995)|
Prothese, Femurkopf (16-125)
Prothese, Gelenk, Hüfte, Acetabulum-Komponente (16-084)
Schraube, Knochen (16-101)
|Manufacturer||LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H.|