Health product recall

Philips Multidiagnost Eleva, Allura Xper and Azurion systems

Last updated

Summary

Product
Philips Multidiagnost Eleva, Allura Xper and Azurion systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Allura Xper Fd20 Or Table (Product Of Alluraclarity Family)

Contact the manufacturer.

722035

Allura Xper Fd10/10 (Product Of Alluraclarity Family)

Contact the manufacturer.

722027

Allura Xper Fd20/20 (Product Of Alluraclarity Family)

Contact the manufacturer.

722038

Azurion 7 M12

Contact the manufacturer.

722 223
722 078

Azurion 7 M20

Contact the manufacturer.

722 224
722 079

Azurion 7 B20

Contact the manufacturer.

722 226
722 068

Multidiagnost Eleva - Image Intensifier - Tv Image Detector

Contact the manufacturer.

0708MD02

Allura Xper Fd10

Contact the manufacturer.

ALLURA XPER FD10 001443

Multidiagnost Eleva - Flat Detector - Image Detector

Contact the manufacturer.

0708MD02

Allura Xper Fd10 (Product Of Alluraclarity Family)

Contact the manufacturer.

722026

Allura Xper Fd20 (Product Of Alluraclarity Family)

Contact the manufacturer.

722028

Azurion 7 B12

Contact the manufacturer.

722 067

Allura Xper Fd20/10 (Product Of Alluraclarity Family)

Contact the manufacturer.

722029

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74140

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