ALLURA XPER and AZURION 7
CanadaALLURA XPER and AZURION 7
Recalling Firm: Medical devices
Reason for Recall / Hazard
TranslatedSoftware defect
Product Description & Identification
TranslatedThe actions that should be taken by the user in order to prevent risks for patients or users•Ensure that the wired foot switch is always connected to the system. The wired footswitch is always provided with the AlluraXper and the Azurion systems.•Immediately start using the wired foot switch in case the wireless foot switch loses connection.•Circulate this notice to all users of this device so that they are aware of the issue.•Place this Urgent Medical Device Recall Letter with the documentation of the Philips AlluraXper or Azurion system.•Return the attached Urgent Medical Device Recall Letter Response Form to Philips to confirm that:o the Allura Xper and Azurion system wired foot switch is connected to the systemo the users of the system have reviewed and understood this Urgent Medical Device Recall Letter.
Affected Products
TranslatedALLURA XPER and AZURION 7
Additional Source Details
| Field | Value |
|---|---|
| N I D | 63591 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/allura-xper-and-azurion-7 |
| Issue | Software defect |
| Title | ALLURA XPER and AZURION 7 |
| Product | ALLURA XPER and AZURION 7 |
| Archived | 0 |
| Category | Radiology |
| Last updated | 2021-11-12 |
| Organization | Medical devices |
| Recall class | Type II |
| What you should do | The actions that should be taken by the user in order to prevent risks for patients or users•Ensure that the wired foot switch is always connected to the system. The wired footswitch is always provided with the AlluraXper and the Azurion systems.•Immediately start using the wired foot switch in case the wireless foot switch loses connection.•Circulate this notice to all users of this device so that they are aware of the issue.•Place this Urgent Medical Device Recall Letter with the documentation of the Philips AlluraXper or Azurion system.•Return the attached Urgent Medical Device Recall Letter Response Form to Philips to confirm that:o the Allura Xper and Azurion system wired foot switch is connected to the systemo the users of the system have reviewed and understood this Urgent Medical Device Recall Letter. |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought ALLURA XPER and AZURION 7?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmMedical devices
- Risk LevelType II
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