On 14th october, 2020 getinge became aware of an issue with surgical light ¿ lucea.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.
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On 14th october, 2020 getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.The device involved in the event is lucea 40 with serial number (b)(6) and catalog number ard568601998.Manufacturing date is 15th of september 2011.It was established that when the event occurred, the examination light did not meet its specification due to headlight detachment and it contributed to the issue.It is unknown if the device was being used for patient examination.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.The manufacturer¿s subject matter experts have investigated the issue.Unfortunately, the specific root cause wasn¿t possible to be established due to lack of information, despite our best efforts.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of b5.Describe event or problem deem required.This is based on the internal evaluation.Previous b5.Describe event or problem: on 14th october, 2020 getinge became aware of an issue with surgical light ¿ lucea.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.Corrected b5.Describe event or problem: on 14th october, 2020 getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.
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On 14th october, 2020 getinge became aware of an issue with examination light ¿ lucea 40.As it was stated, the headlight has detached from the arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.Manufacturer's reference number (b)(4).
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