Philips Recalls Azurion Imaging Systems Over Software Flaws in Canada

Health Canada has issued a health product recall for Philips Azurion imaging systems after the manufacturer identified two software-related issues that could delay therapy, cause procedural complications, or lead to inappropriate treatment during medical imaging procedures.

What Products Are Being Recalled?

The recall affects multiple Azurion system models manufactured by Philips Medical Systems Nederland, including the Azurion 7 M12, Azurion 7 B12, Azurion 5 M20, Azurion 7 M20, and Azurion 7 B20. These systems run on software versions R2.x.10, R3.0, R3.1 and R4.0. Affected units are identified by catalogue numbers including 722233, 722223, 722078, 722067, 722235, 722232, 722224, 722079, 722234, 722068, 722226 and 722236. No lot or serial numbers apply to this recall, as the issue is tied to software rather than a specific manufacturing batch.

Why Was This Recall Issued?

Philips identified two separate software-related issues affecting the Azurion systems. The first issue involves image quality degradation, which could compromise the clarity of images used to guide medical procedures. The second issue involves loss of geometry movements, which applies specifically to systems equipped with an AD7X table. Both issues could result in a delay of therapy, procedural complications, and/or inappropriate treatment for patients undergoing imaging-guided procedures.

Who Is Affected?

This recall is directed at the healthcare audience, specifically hospitals, clinics, and medical facilities in Canada that use Azurion imaging systems for radiology procedures. Health Canada has classified this as a Type II recall, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Patients undergoing procedures that rely on Azurion systems for imaging guidance could be indirectly affected if the software issues are not addressed by facility staff.

What Should You Do?

Healthcare facilities and staff operating affected Azurion systems should contact Philips Medical Systems Nederland B.V. directly for additional information regarding the software issues and any corrective actions. Facilities should follow any guidance provided by Philips regarding software updates or operational precautions until the issues are resolved. Any healthcare provider with concerns about a specific device or patient safety incident involving these systems is encouraged to report the issue through Health Canada’s official reporting channels.

Official Statement

According to Health Canada’s official recall notice, Philips has identified two software-related issues affecting Azurion R2.x.10, R3.0, R3.1 and R4.0 systems that may result in delay of therapy, procedural complications and/or inappropriate treatment. The notice specifies that Issue 1 involves image quality degradation, while Issue 2 involves loss of geometry movements, applicable only to systems with an AD7X table. The recall was published by Health Canada with an identification number of RA-82414 and a recall date of 2026-07-24.