Safety Alerts

Health Canada has posted a medical device safety alert concerning Philips Medical Systems Nederland B.V. Multidiagnost Eleva, Allura Xper and Azurion systems [Multiple model or catalog numbers] [HKMD No.: 100205, 100206, 110046, 110047, 110048, 200480].

According to Health Canada, the manufacturer has become aware of a potential safety issue with the wired and wireless foot switch used with the Philips Multidiagnost Eleva, Allura Xper and Azurion systems, where there is a possibility of unintended radiation. The wired and wireless foot switch are used to control fluoroscopy, exposure and other functions, such as single shot, light control and toggle between x‐ray planes (for bi‐plane systems). A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation, because of:

• Build‐up of dense or sticky fluids on the foot switch (e.g., blood or contrast fluid), if not properly cleaned.
• Use of protective covers that are either the wrong size or incorrectly placed on the foot switch.
• Dislodgement of a screw holding the handle of the foot switch, subsequently becoming lodged within the foot switch housing.
• An additional screw inadvertently left inside the foot switch housing during manufacturing.

For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/philips-multidiagnost-eleva-allura-xper-and-azurion-systems#tablefield-node-74140-field_affected_products-0

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 22 Aug 2023