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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.

Field Safety Corrective Action for the OctoNova Hemofiltration Device, Nikkiso Europe GmbH , Download_VeroeffentlichtAm_EN PDF, 373KB, File does not meet accessibility standards

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