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Allura xper and azurion 7

Official notice

12 Nov 2021

Last checked

12 Nov 2021

Medium riskHealth Canada

An official Health Canada notice concerns Allura xper and azurion 7. Allura xper and azurion 7 Published 2021-11-12.

What to do now

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.

Recall number

63591

Official notice

2021-11-12

The hazard

Allura xper and azurion 7

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63591

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Allura Xper And Azurion 7.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63591

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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