Philips Recalls Allura Xper and Azurion Systems Due to X-ray Imaging Failures

What Happened

Philips Medical Systems Nederland B.V. has identified a technical issue with certain Allura Xper and Azurion imaging systems. The company found that X-ray imaging may fail to initiate or may occur only intermittently when using the system’s wired foot switch.

According to the investigation, the failure is attributed to several potential factors: internal or external damage to cables and connectors, internal microswitch failures within the foot switch pedals, and issues with foot switch connectors caused by missing or incorrectly applied strain relief. Each foot switch pedal is designed to activate two independent microswitches; X-rays are only released when both are successfully activated.

Which Products Are Affected

The recall affects several models within the Allura Xper and Azurion families. The following model or catalogue numbers are included:

• Allura Xper FD10 (AlluraClarity Family): 722026
• Allura Xper FD10/10 (AlluraClarity Family): 722027
• Azurion 7 M20: 722224, 722079, 722234
• Allura Xper FD20/15: 722058
• Allura Xper FD10: 001443
• Allura Xper FD20/10 (AlluraClarity Family): 722029
• Azurion 7 M12: 722233, 722223, 722078
• Azurion 3 M12: 722063

What You Should Do

Healthcare providers and facilities using these systems should be aware of the potential for intermittent X-ray operation. While the source data does not specify a direct return process, users should monitor the performance of the wired foot switches and contact Philips Medical Systems Nederland B.V. regarding the identified hardware failures and strain relief issues.

Why This Matters

The inability to initiate X-ray imaging or the occurrence of intermittent imaging during a clinical session is a significant safety concern. Such failures could potentially result in the delay or the complete abortion of a medical procedure, impacting patient care.

Source

Health Canada Recall Alert