No image published for this recall

No image published for this recall

Azurion 7 system

Official notice

5 Jan 2024

Last checked

5 Jan 2024

Medium riskHealth Canada

An official Health Canada notice concerns Azurion 7 system. Philips has become aware of a potential safety issue with the Philips Azurion Systems R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2, where the system may exhibit a loss of imaging functionality and data. Philips has identified a potential issue which can cause the system to continuously restart (restart loop). T his is likely to occur when the patient database gets too big over time (>500 studies). If this issue occurs, a potential for data loss may be expected. Recall start date: December 15, 2023 Published 2024-01-05.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74861

Official notice

2024-01-05

The hazard

Philips has become aware of a potential safety issue with the Philips Azurion Systems R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2, where the system may exhibit a loss of imaging functionality and data. Philips has identified a potential issue which can cause the system to continuously restart (restart loop). T his is likely to occur when the patient database gets too big over time (>500 studies). If this issue occurs, a potential for data loss may be expected. Recall start date: December 15, 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

74861

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Affected products

Product 1

Affected products - Azurion 7 M20, Lot or serial number - Not applicable., Model or catalog number - 722 224 722 079

Product 2

Affected products - Azurion 7 B20, Lot or serial number - Not applicable., Model or catalog number - 722 226 722 068

Product 3

Affected products - Azurion 5 M20, Lot or serial number - Not applicable., Model or catalog number - 722228

Product 4

Affected products - Azurion 7 B12, Lot or serial number - Not applicable., Model or catalog number - 722 067

Product 5

Affected products - Azurion 7 M12, Lot or serial number - Not applicable., Model or catalog number - 722 223 722 078

Product 6

Affected products - Azurion 5 M12, Lot or serial number - Not applicable., Model or catalog number - 722 227

Risk / hazard

Philips has become aware of a potential safety issue with the Philips Azurion Systems R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2, where the system may exhibit a loss of imaging functionality and data. Philips has identified a potential issue which can cause the system to continuously restart (restart loop). T his is likely to occur when the patient database gets too big over time (>500 studies). If this issue occurs, a potential for data loss may be expected. Recall start date: December 15, 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 System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74861

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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