Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. Wired Foot Switch used with Philips Allura Xper, Allura Centron, Azurion and Multidiagnost‐Eleva systems [Multiple model or catalogue number] [HKMD No.: 100205, 100206, 110046, 110047, 110048, 120208, 200480].
According to Health Canada, the manufacturer 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.
According to the manufacturer, 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.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/philips-wired-foot-switch#tablefield-node-74216-field_affected_products-0
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 Aug 2023