Safety Alert Summary

Safety Alert Summary

Medical Device Safety Alert: Acutronic Medical Systems AG (Sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia) fabian HFO Classic and fabian HFOi Neonatal and Pediatric Ventilators [fabian HFO Classic (Model Number: 112001; UDI: 17640140860203; Software Version: SW v5.2.2) & fabian HFOi (Model Number: 113001; UDI: 17640140860043; Software Version: SW v5.2.2)]

16 May 2024

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00376-1

Posted on 16 May 2024

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