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Azurion 7 systems

Official notice

12 Jun 2025

Last checked

12 Jun 2025

Medium riskHealth Canada

An official Health Canada notice concerns Azurion 7 systems. Philips has identified a software issue in the internal communication process between the system software and the X-ray generator firmware. This issue may be triggered under either of the following situations: Situation 1 - Pedal Tap: When the foot switch is pressed and released rapidly without generating X-rays (due to a short duration of contact), the system may enter a state where Xray generation is inhibited. When this occurs, the system does not show any message to the user indicating that X-ray is not possible. A warm restart may resolve the situation in some cases. A cold restart will always resolve the situation. Situation 2 - Phase Fault: Azurion systems are designed to automatically recover from phase faults (a phase fault is an abnormal condition in which one or more phase voltages drop to (near) zero). When a phase fault occurs, the X-ray generator software initiates an automatic recovery process to restore fully system functionality, during which imaging (X-ray) functionality is not available for approximately 5 seconds. When the identified software issue occurs during this recovery, communication with the system software is lost, resulting in the system not recognizing that the generator has recovered and is ready for operation. In this situation, the system shows the user message "generator is busy starting up, no X-ray possible". If the phase fault is detected by the generator during acquisition, the system also shows the message "run aborted: tube problem". To restore system functionality a cold restart of the system is required. Recall start date: June 4, 2025 Published 2025-06-12.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77587

Official notice

2025-06-12

The hazard

Philips has identified a software issue in the internal communication process between the system software and the X-ray generator firmware. This issue may be triggered under either of the following situations: Situation 1 - Pedal Tap: When the foot switch is pressed and released rapidly without generating X-rays (due to a short duration of contact), the system may enter a state where Xray generation is inhibited. When this occurs, the system does not show any message to the user indicating that X-ray is not possible. A warm restart may resolve the situation in some cases. A cold restart will always resolve the situation. Situation 2 - Phase Fault: Azurion systems are designed to automatically recover from phase faults (a phase fault is an abnormal condition in which one or more phase voltages drop to (near) zero). When a phase fault occurs, the X-ray generator software initiates an automatic recovery process to restore fully system functionality, during which imaging (X-ray) functionality is not available for approximately 5 seconds. When the identified software issue occurs during this recovery, communication with the system software is lost, resulting in the system not recognizing that the generator has recovered and is ready for operation. In this situation, the system shows the user message "generator is busy starting up, no X-ray possible". If the phase fault is detected by the generator during acquisition, the system also shows the message "run aborted: tube problem". To restore system functionality a cold restart of the system is required. Recall start date: June 4, 2025

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

77587

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Affected products

Product 1

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

Product 2

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

Product 3

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

Product 4

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

Risk / hazard

Philips has identified a software issue in the internal communication process between the system software and the X-ray generator firmware. This issue may be triggered under either of the following situations: Situation 1 - Pedal Tap: When the foot switch is pressed and released rapidly without generating X-rays (due to a short duration of contact), the system may enter a state where Xray generation is inhibited. When this occurs, the system does not show any message to the user indicating that X-ray is not possible. A warm restart may resolve the situation in some cases. A cold restart will always resolve the situation. Situation 2 - Phase Fault: Azurion systems are designed to automatically recover from phase faults (a phase fault is an abnormal condition in which one or more phase voltages drop to (near) zero). When a phase fault occurs, the X-ray generator software initiates an automatic recovery process to restore fully system functionality, during which imaging (X-ray) functionality is not available for approximately 5 seconds. When the identified software issue occurs during this recovery, communication with the system software is lost, resulting in the system not recognizing that the generator has recovered and is ready for operation. In this situation, the system shows the user message "generator is busy starting up, no X-ray possible". If the phase fault is detected by the generator during acquisition, the system also shows the message "run aborted: tube problem". To restore system functionality a cold restart of the system is required. Recall start date: June 4, 2025

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.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77587

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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