Changeflow GovPing Healthcare & Life Sciences Philips Recalls Allura Xper/Azurion Systems for...
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Philips Recalls Allura Xper/Azurion Systems for X-ray Imaging Issues

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Summary

Health Canada issued a recall for Philips Allura Xper and Azurion X-ray imaging systems due to performance issues with the wired foot switch. The recall affects multiple models and advises healthcare providers to contact the manufacturer for additional information.

Published by Health Canada on recalls-rappels.canada.ca . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

Health Canada has issued a Type II recall for Philips Allura Xper and Azurion Systems due to potential X-ray imaging issues. The problem stems from cable or connector damage, internal microswitch failure, or foot switch connector issues, which could lead to no or intermittent X-ray initiation. This may cause delays or aborts in medical procedures.

Healthcare providers using these systems are advised to contact Philips Medical Systems Nederland B.V. for additional information. While no specific compliance deadline or penalty is mentioned, the recall highlights potential patient safety risks and operational disruptions. Affected parties should review their equipment and consult with the manufacturer to understand the implications and necessary actions.

What to do next

  1. Review Philips Allura Xper and Azurion systems for potential foot switch issues.
  2. Contact Philips Medical Systems Nederland B.V. for additional information and guidance.
  3. Assess potential impact on patient procedures and operational continuity.

Archived snapshot

Mar 17, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Health product recall

Allura Xper and Azurion Systems

Brand(s)

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Last updated

2026-03-17

Summary

Product 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 catalogue number
Allura Xper FD10 (Product Of AlluraClarity Family) Not applicable. 722026
Allura Xper FD10/10 (Product Of AlluraClarity Family) Not applicable. 722027
Azurion 7 M20 Not applicable. 722 224
Azurion 7 M20 Not applicable. 722 079
Azurion 7 M20 Not applicable. 722234
Allura Xper FD20/15 Not applicable. 722058
Allura Xper FD10 Not applicable. 001443
Allura Xper FD20/10 (Product Of AlluraClarity Family) Not applicable. 722029
Azurion 7 M12 Not applicable. 722233
Azurion 7 M12 Not applicable. 722 223
Azurion 7 M12 Not applicable. 722 078
Azurion 3 M12 Not applicable. 722 063
Azurion 3 M12 Not applicable. 722 221
Azurion 3 M12 Not applicable. 722229
Azurion 5 M12 Not applicable. 722 227
Azurion 5 M12 Not applicable. 722231
Azurion 5 M20 Not applicable. 722 228
Azurion 5 M20 Not applicable. 722232
Allura Xper FD20 (Product Of AlluraClarity Family) Not applicable. 722028
Allura Xper FD20/20 (Product Of AlluraClarity Family) Not applicable. 722038
Azurion 7 B20 Not applicable. 722 226
Azurion 7 B20 Not applicable. 722236
Azurion 7 B20 Not applicable. 722 068
Azurion 3 M15 Not applicable. 722230
Azurion 3 M15 Not applicable. 722 064
Azurion 3 M15 Not applicable. 722 222
Azurion 7 B12 Not applicable. 722 067
Azurion 7 B12 Not applicable. 722235
Azurion 7 B12 Not applicable. 722 225
Allura Xper FD20 Or Table (Product Of AlluraClarity Family) Not applicable. 722035

Issue

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch due to:

  • cable or connector damage (internal and/or external)
  • internal microswitch failure (each foot switch pedal activates two independent microswitches that - when both activated - release X-ray)
  • foot switch connector issues resulting from missing or incorrectly applied strain relief No or intermittent X-ray could potentially result in a delay or abort of procedure.

Additional information

Details

Original published date:

2026-03-17

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 Recall date

2026-03-03

Identification number RA-81765

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Last updated

Classification

Agency
Health Canada
Published
March 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers
Geographic scope
Canada Canada

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices Product Safety

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