Health Canada — Medical Devices · Canada · 2019-03-15 · Type II
As described by Health Canada — Medical Devices: Achieva 1.5T, 3.0T, XR MRI Systems, Intera 1.5T, 3.0T MRI Systems, Ingenia 1.5T, 3.0T, 3.0T CX, Ingenia Elition X, and Panorama HFO (2018-12-17)
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Reported risk: Philips MR systems are standard equipped with two ceiling speakers, positioned in the front and/or rear of the MR system. These speakers enable communication between the operator in the examination room and the patient and offer stereo music or ambient experience audio. These speakers are in most cases fixated in the suspended ceiling of the MR examination room according the Philips service instructions. The Philips Planning Reference Data (PRD) prescribes the suspended ceiling must be strong enough to hold 25 N speakers. However in very rare cases, due to external influences (hospital facility maintenance, water leakage, degradation of speaker fixation) during the lifetime of the MR system, the ceiling speaker(s) could fall from their position and be pulled to the MR system by the magnetic field.
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