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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00851-1
Product Name/Description SoKINOX NO (Nitric Oxide) Delivery and Monitoring System

Device Number: 66 94 550

ARTG Number: 273803
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/07/2017
Responsible Entity Maquet Australia Pty Ltd
Reason/Issue Getinge has identified an issue where during NO (Nitric Oxide) therapy, when a NO cylinder runs nearly empty the system will indicate this by the "almost empty cylinder" icon. When the cylinder runs empty it will then trigger the alarm NO cylinder 1 missing (or empty) or NO cylinder 2 missing (or empty). This is indicated on the user interface by a crossed out cylinder icon. The system automatically shifts over to the other cylinder.

Due to a pressure increase after the cylinder switch-over there are two possible issues identified:
1. The cylinder status icon can change and erroneously indicate remaining gas in an empty NO gas cylinder.
2. The alarm “NO cylinder 1 missing (or empty)” or “NO cylinder 2 missing (or empty)” can be deactivated

If the empty NO cylinder is not replaced, both NO cylinders can run empty and cause a stop in NO delivery. To date, there have been no reports of patient injury as a result of this issue.
Recall Action Recall for Product Correction
Recall Action Instructions Getinge/Maquet will initiate an immediate update of all affected SoKINOX systems as soon as the system version 1.3 is released in Australia. Once version 1.3 available, customers will be contacted by a Getinge/Maquet sales or service representative to plan for the update of the device.

This action has been closed out on 19/09/2018
Contact Information 1800 605 824 - Getinge Customer Service