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Azurion 7 m20

Official notice

4 Jan 2024

Last checked

4 Jan 2024

Medium riskHealth Canada

An official Health Canada notice concerns Azurion 7 m20. Philips has become aware of a potential safety issue with the Azurion 7 M20 Flexarm System ("flexarm") with a Maquet Magnus Table with software versions 05.02.12 and 05.02.15 ("table"). Due to a communication issue between the flexarm and the table, motorized movements of the table and/or the flexarm may be lost. A representative of Getinge (manufacturer of the Maquet Magnus Table) will arrange a site visit to return the software of your table to version 05.02.12. After this change, your system will be subject to the medical device recall letter (HS23039R/2023-IGT-BST-020). Recall start date: December 13, 2023 Published 2024-01-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74843

Official notice

2024-01-04

The hazard

Philips has become aware of a potential safety issue with the Azurion 7 M20 Flexarm System ("flexarm") with a Maquet Magnus Table with software versions 05.02.12 and 05.02.15 ("table"). Due to a communication issue between the flexarm and the table, motorized movements of the table and/or the flexarm may be lost. A representative of Getinge (manufacturer of the Maquet Magnus Table) will arrange a site visit to return the software of your table to version 05.02.12. After this change, your system will be subject to the medical device recall letter (HS23039R/2023-IGT-BST-020). Recall start date: December 13, 2023

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

74843

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Affected products

Product 1

Affected products - Azurion 7 M20, Lot or serial number - All lots., Model or catalog number - 722 224

Risk / hazard

Philips has become aware of a potential safety issue with the Azurion 7 M20 Flexarm System ("flexarm") with a Maquet Magnus Table with software versions 05.02.12 and 05.02.15 ("table"). Due to a communication issue between the flexarm and the table, motorized movements of the table and/or the flexarm may be lost. A representative of Getinge (manufacturer of the Maquet Magnus Table) will arrange a site visit to return the software of your table to version 05.02.12. After this change, your system will be subject to the medical device recall letter (HS23039R/2023-IGT-BST-020). Recall start date: December 13, 2023

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, Azurion 7 M20.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74843

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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