Philips Allura Xper Systems Recalled Over Software Issue: Health Canada

Health Canada has published a Type II health product recall for Philips Allura Xper systems, a family of radiology equipment, after the manufacturer identified a software problem affecting the FlexVision application. The recall is listed under identification number RA-82780, with a recall date of October 9, 2026. Health Canada published the notice on October 14, 2026.

The notice is aimed at the healthcare audience. It is not a consumer product alert. The recalled equipment is used in clinical settings, so hospitals and clinics are the ones that need to pay attention.

Regulatory Response

Health Canada classified the action as a Type II recall and listed the issue as a medical device performance problem. The notice covers products in the radiology category and names Philips Medical Systems Nederland B.V., based in Best, Netherlands, as the company involved.

The agency’s guidance is short. It asks anyone who needs more information to contact the manufacturer.

What Went Wrong?

Philips identified a software issue that can cause the FlexVision software application to become unresponsive during clinical use. When that happens, the FlexVision monitor can behave in one of two ways:

• The monitor may turn blank and stop showing live images or other information normally displayed on it.
• The monitor may freeze on the last screen shown and stop updating live images or other information.

According to the notice, a cold system restart is needed to restore normal FlexVision display function. The source does not give a cause for the software fault or say how often it has occurred.

Products Affected by This Recall

The recall covers several configurations of the Allura Xper line, including products from the AlluraClarity family. The notice lists the following product names and model or catalogue numbers:

• Allura Xper FD10 – model ALLURA XPER FD10 and catalogue number 001443
• Allura Xper FD10 (Product Of AlluraClarity Family) – 722026
• Allura Xper FD10/10 (Product Of AlluraClarity Family) – 722027
• Allura Xper FD20 (Product Of AlluraClarity Family) – 722028
• Allura Xper FD20/10 (Product Of AlluraClarity Family) – 722029
• Allura Xper FD20 OR Table (Product Of AlluraClarity Family) – 722035
• Allura Xper FD20/20 (Product Of AlluraClarity Family) – 722038
• Allura Xper FD20/15 – 722058

The notice marks lot and serial numbers as not applicable for every entry, so the model or catalogue number is what identifies an affected system. It does not state how many units are affected.

Who Should Be Concerned

The recall is directed at healthcare facilities and professionals that operate Allura Xper systems in Canada. Because the display problem can arise during clinical use, staff who work with these systems should know the two ways the FlexVision monitor can fail and that a cold restart is the stated way to restore it.

Patients do not need to take any action based on this notice. Facilities with questions about a specific system can raise them with the manufacturer.

What Healthcare Facilities Need to Do Now

The only instruction in the notice is to contact the manufacturer if more information is needed. Facilities may want to:

• Check their equipment inventory against the model and catalogue numbers listed above.
• Make sure clinical staff know that the FlexVision monitor can go blank or freeze.
• Note that a cold system restart is required to restore normal FlexVision display function.
• Contact Philips Medical Systems Nederland B.V. for further details about the issue and any next steps.

The notice does not describe a corrective software update, a repair or a replacement. It also gives no contact details for the manufacturer, so facilities should use their existing Philips service channels.

From the Agency

Health Canada published the recall on its recalls and safety alerts website under the Health product recall category, in the Medical devices and Radiology section. The listing was last updated on October 14, 2026. The agency lists the issue as a performance problem and the recall class as Type II.

Healthcare professionals can sign up for email notifications on new and updated recalls through the Health Canada recalls site. Anyone who has a health or safety concern about a product can report it to Health Canada through its online reporting service.

Quick Facts

• Product: Philips Allura Xper Systems
• Manufacturer: Philips Medical Systems Nederland B.V.
• Recall number: RA-82780
• Recall class: Type II
• Recall date: 2026-10-09
• Issue: FlexVision software may become unresponsive during clinical use
• Fix noted: Cold system restart restores normal display function