Philips Achieva & Ingenia MR systems (2021-04-30) — recall 62406
Health Canada — Medical Devices · Canada · 2021-05-13 · Type II
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Reported risk: For the following MR systems manual in (or out) movement of the tabletop is not completely possible: Ingenia 1.5T, Ingenia 1.5T (s), Ingenia 1.5T CX, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition S, Ingenia Elition X, Smartpath to Dstream 1.5T, Smartpath to Dstream for XR and 3.0T. The horizontal tabletop movement can be either motorized or in manual mode. Manual mode means that the tabletop is moved manually by pushing or pulling the tabletop handgrip by the operator. When the horizontal movement is in manual mode, the tabletop outward motion may be blocked while the table is only partly out of the bore. This is due to a mechanical failure (wrong gear profile). An unacceptable hazardous situation could occur, when the tabletop is in 'manual' mode during a quick evacuation of the patient from the MR system.
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