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Azurion 3 and 7

Official notice

14 Aug 2024

Last checked

14 Aug 2024

Medium riskHealth Canada

An official Health Canada notice concerns Azurion 3 and 7. Philips has identified two issues in software version R1.X of the Philips Azurion system that may affect: a) Management of the system log trace files: The mechanism that is present in the system to manage the number and size of the system log trace files does not function properly, as a result of which the log trace files related to remote connection logging may occupy the full hard disk capacity of the Philips Azurion R1.X system. When the full disk capacity is reached, imaging (X-ray) functionality will cease to be available without an advance warning to the user. A restart of the system will not resolve the issue. Note: This issue only impacts the Philips Azurion R1.X systems that are currently connected to Philips remote service or that were connected in the past. B) Time to perform a cold restart: A cold restart of the Philips Azurion R1.X system may take up to 6 minutes as stated in the instructions for use of the system (section 4.2). This time includes the time required for the system to shut down and the system to start up. However, there are instances where the shutdown of the system may be prolonged (with up to 4 minutes) resulting in the cold restart taking longer (up to 10 minutes in total). Recall Start Date: July 17, 2024 Published 2024-08-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75918

Official notice

2024-08-14

The hazard

Philips has identified two issues in software version R1.X of the Philips Azurion system that may affect: a) Management of the system log trace files: The mechanism that is present in the system to manage the number and size of the system log trace files does not function properly, as a result of which the log trace files related to remote connection logging may occupy the full hard disk capacity of the Philips Azurion R1.X system. When the full disk capacity is reached, imaging (X-ray) functionality will cease to be available without an advance warning to the user. A restart of the system will not resolve the issue. Note: This issue only impacts the Philips Azurion R1.X systems that are currently connected to Philips remote service or that were connected in the past. B) Time to perform a cold restart: A cold restart of the Philips Azurion R1.X system may take up to 6 minutes as stated in the instructions for use of the system (section 4.2). This time includes the time required for the system to shut down and the system to start up. However, there are instances where the shutdown of the system may be prolonged (with up to 4 minutes) resulting in the cold restart taking longer (up to 10 minutes in total). Recall Start Date: July 17, 2024

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

75918

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Affected products

Product 1

Affected products - Azurion 3 M15, Lot or serial number - Not applicable., Model or catalog number - 722 064

Product 2

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

Product 3

Affected products - Azurion 3 M12, Lot or serial number - Not applicable., Model or catalog number - 722 063

Product 4

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

Product 5

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

Product 6

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

Risk / hazard

Philips has identified two issues in software version R1.X of the Philips Azurion system that may affect: a) Management of the system log trace files: The mechanism that is present in the system to manage the number and size of the system log trace files does not function properly, as a result of which the log trace files related to remote connection logging may occupy the full hard disk capacity of the Philips Azurion R1.X system. When the full disk capacity is reached, imaging (X-ray) functionality will cease to be available without an advance warning to the user. A restart of the system will not resolve the issue. Note: This issue only impacts the Philips Azurion R1.X systems that are currently connected to Philips remote service or that were connected in the past. B) Time to perform a cold restart: A cold restart of the Philips Azurion R1.X system may take up to 6 minutes as stated in the instructions for use of the system (section 4.2). This time includes the time required for the system to shut down and the system to start up. However, there are instances where the shutdown of the system may be prolonged (with up to 4 minutes) resulting in the cold restart taking longer (up to 10 minutes in total). Recall Start Date: July 17, 2024

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 3 And 7.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75918

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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