Field Safety Corrective Action for the OctoNova Hemofiltration Device, Nikkiso Europe GmbH
2012.07.26
Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 01343/12
The company Nikkiso Europe GmbH has initiated a field safety corrective action to the OctoNova Hemofiltration Device. In software version 4.30.xx the “TMP2min” alarm is not working as defined in the specifications. The manufacturer will install a new software version 4.30.04. Users were notified of the issue.