On (b)(6) 2024 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, the light body was damaged due to impact.As a result, the headlight's cover was taped to prevent it from falling.The designated complaint unit employee confirmed based on the photographic evidence that the reported issue occurred and an additional problem of the screw missing from fork was found.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
|