Medical device manufacturer, Getinge, has issued a medical device alert concerning its SERViNO and SoKINOX NO delivery and monitoring system. According to the local supplier, the affected devices are identified as following:

• SERViNO delivery and monitoring system
  • Article no.: 6881700
  • Batch number: 20009, 20021, 20025, 20030, 20053, 20054, 20055, 20056, 20072, 20073, 20074, 20075, 20076, 20099
• SoKINOX NO delivery and monitoring system
  • Article number: 6694550
  • Batch number: 203

The manufacturer has received a number of reports regarding leakage due to malfunction of the pilot valve in the backup system. If the system is not in use and the cylinders are left open at the same time, the leakage could drain the connected Nitric Oxide (NO) gas cylinders. The manufacturer will arrange a replacement pilot valve to the affected units.

According to the manufacturer, the device can be safely used as intended if the instructions in the user manual are followed:

• Ensure that the NO cylinders are always closed when the system is not in use.
• Before usage always check the available NO pressure in the cylinder by checking the pressure gauge on the NO gas regulator mounted on the cylinder.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary action.

Posted on 25 January 2021