Philips has become aware of a potential safety issue with the wired foot switch used with the Philips Allura Xper, Allura Centron, Azurion and Multidiagnost‐Eleva systems, where there is a possibility of loss of imaging functionality resulting from no or intermittent x‐ray radiation initiation. The wired foot switch is used to control fluoroscopy, exposure and other functions like single shot, light control, and toggle between x‐ray planes (for bi‐plane system), this in combination with the above‐mentioned Philips systems. Evaluation of complaints received identified situations where there is a possibility for no or intermittent x‐ray radiation related to this wired foot switch. If there is no or intermittent x‐ray radiation this will lead to loss of imaging functionality which may result in delayed diagnosis or interruption of procedure. Recall start date: August 18, 2023
RecallTracker