On february 29, 2024 getinge became aware of an issue related to the automation loading system with the model name: ags 2.0.The getinge ags 2.0 is not registered as a medical device, however upon the situation occurrence it was used with the four medical devices - 86-series washer disinfectors with the model name: 8668.As it was stated, the rack almost fell on the floor.Gathered information allowed us to establish that device was restarted and it was returned to the service in full working condition.There was no allegation of injury however, we decided to report the issue based on a potential as a rack falling to the floor could bring a hazardous situation for the operator and lead to serious injury if the situation.
|