On (b)(6) 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.As it was stated, headlight handle was broken.The designated complaint unit employee confirmed based on photographic evidence that the side positioning handle was fractured and taped.There was no injury reported, however, considering the worse case scenario some particles of the handle could detach from the device and fall off, therefore, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
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