| 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 |
|
| 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 |