On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - volista standop 400.According to the customer allegation during the operator's handling of the surgical procedure, the dome hit an air filter in the false ceiling of the operating room, causing it to fall on the surgeon's head.The air filter was hit because the height of the spring arm was not correctly adjusted.Medical intervention was required on the surgeon who was affected.The surgeon received 4 stitches for a cut to his head.Spring arm height adjustment of both domes was performed, repair was completed, the arm movement tests carried out with positive results.The outcome as described is consider to meet the definition of a serious injury.(b)(4).
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