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Allura xper fd10 and fd20 10 (product of alluraclarity family)

Official notice

25 Nov 2021

Last checked

25 Nov 2021

Medium riskHealth Canada

An official Health Canada notice concerns Allura xper fd10 and fd20 10 (product of alluraclarity family). A problem has been identified in the Philips Allura Xper and Azurion systems that could pose a risk for patients. Philips has discovered that the wireless foot switch can suddenly stop responding due to a firmware bug when a number of ambient conditions coexist, such as EMC disturbance and the presence of other wireless devices in the room. The wireless footswitch is an option to Philips Allura Xper and Azurion systems to release live Fluoroscopy and exposure. Recovery of this error can be done by means of a cold restart of the system [power down, power up], which restores the functionality of the base station. Recall start date: 2021-10-25 Published 2021-11-25.

What to do now

Contact the manufacturer if you require additional information

Recall number

63647

Official notice

2021-11-25

The hazard

A problem has been identified in the Philips Allura Xper and Azurion systems that could pose a risk for patients. Philips has discovered that the wireless foot switch can suddenly stop responding due to a firmware bug when a number of ambient conditions coexist, such as EMC disturbance and the presence of other wireless devices in the room. The wireless footswitch is an option to Philips Allura Xper and Azurion systems to release live Fluoroscopy and exposure. Recovery of this error can be done by means of a cold restart of the system [power down, power up], which restores the functionality of the base station. Recall start date: 2021-10-25

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

63647

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Affected products

Product 1

Affected Products - ALLURA XPER FD10, Lot or serial number - Not applicable, Model or catalog number - 001443 ALLURA XPER FD10

Product 2

Affected Products - ALLURA XPER FD20/10 (PRODUCT OF ALLURACLARITY FAMILY), Lot or serial number - Not applicable, Model or catalog number - 722029

Risk / hazard

A problem has been identified in the Philips Allura Xper and Azurion systems that could pose a risk for patients. Philips has discovered that the wireless foot switch can suddenly stop responding due to a firmware bug when a number of ambient conditions coexist, such as EMC disturbance and the presence of other wireless devices in the room. The wireless footswitch is an option to Philips Allura Xper and Azurion systems to release live Fluoroscopy and exposure. Recovery of this error can be done by means of a cold restart of the system [power down, power up], which restores the functionality of the base station. Recall start date: 2021-10-25

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: Philips, Allura Xper Fd10 And Fd20 10.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63647

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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