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Philips multidiagnost eleva, allura xper and azurion systems
Official notice
21 Aug 2023
Last checked
21 Aug 2023
An official Health Canada notice concerns Philips multidiagnost eleva, allura xper and azurion systems. Philips 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. Philips has not received any reports of harm resulting from sticking foot switches. Recall Start Date: August 9, 2023 Published 2023-08-21.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74140
Official notice
2023-08-21
The hazard
The hazard
Philips 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. Philips has not received any reports of harm resulting from sticking foot switches. Recall Start Date: August 9, 2023
How to check if you're affected
How to check if you're affected
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The source does not list specific retailers. See the official notice for where affected products were sold.
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Brand: Philips.
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