It was reported that the camera head cannot be changed from the color bar screen.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10.H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed and no deficiencies were observed.The reported malfunction was not observed during functional evaluation.The complaint was not verified.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.
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