X-Ray Failure Risk Prompts Recall of Philips C-Arm Imaging Systems

Health Canada has classified a Type II recall for two Philips mobile imaging systems used in hospitals and clinics across the country, after the manufacturer identified a manufacturing-related defect that can cause the machines to lose X-ray imaging capability mid-procedure. The recall, issued under identification number RA-82610, covers the Veradius Unity and the BV Pulsera Mobile C-Arm System in both its 9-inch and 12-inch versions.

According to Health Canada, the problem originates with air bubbles that can develop inside the monoblock oil of the imaging unit. This tends to happen when there is a long gap between the time a system is manufactured and when it is finally installed and put into clinical use, for example due to extended storage or shipping delays.

What Went Wrong

During a clinical procedure, if a trapped air bubble reaches the high-voltage area of the monoblock while the operator activates X-ray imaging, it can trigger an internal electrical discharge known as a flashover. When that occurs, the system fails to generate X-rays, meaning no image appears on the examination monitor. The unit typically responds by displaying an error message stating that the X-ray generator is unavailable.

Philips notes that in some cases, restarting the system, a process that takes roughly five minutes, can restore normal X-ray generation. The company’s internal investigation traced the issue to the early period of use following a long pre-installation holding time. Systems considered potentially affected are those where more than 300 days passed between manufacture and installation, and fewer than 250 days have elapsed since installation with continued use. As the monoblock oil warms with ongoing operation, storage-related air bubbles are expected to gradually dissipate on their own.

Products Affected by This Recall

• Veradius Unity – model or catalogue number 718132
• BV Pulsera Mobile C-Arm System (9in. and 12in. versions) – model or catalogue number 718095

Health Canada notes that no specific lot or serial number applies to this recall; instead, eligibility is tied to the manufacture-to-installation and installation-to-current-use timeframes described above. The products are manufactured by Philips Medical Systems Nederland B.V., based in Best, Netherlands, and distributed to healthcare facilities that use them for fluoroscopic and radiographic imaging during surgical and interventional procedures.

Who Should Be Concerned

This alert is directed at healthcare facilities and clinical staff who operate Veradius Unity or BV Pulsera mobile C-arm systems, rather than at the general public. Hospitals, surgical centers, and imaging departments that received units meeting the affected manufacture-and-installation window are the primary audience for this notice.

Because the failure occurs during active use, the greatest practical concern is a temporary loss of imaging capability in the middle of a procedure. Health Canada’s Type II classification reflects a situation that could cause temporary or medically reversible adverse consequences, rather than a risk of permanent harm, though any unexpected interruption during an imaging-guided procedure carries clinical significance.

What Consumers Need to Do Now

Health Canada’s guidance for this alert is straightforward: facilities operating an affected system should contact the manufacturer directly if they require additional information or believe their equipment falls within the identified risk window. Clinical staff encountering the X-ray generator unavailable error during a procedure can attempt a system restart, which Philips indicates may restore imaging function in many cases.

Facilities are also encouraged to remain alert to the specific error messaging described in the notice and to report any recurring issues through their normal biomedical engineering or equipment servicing channels, in addition to reaching out to Philips.

Regulatory Response

Health Canada published the alert on September 9, 2026, with the underlying recall dated September 1, 2026. The notice is filed under the Health Canada Medical Devices category, subject area Radiology, and is directed at a healthcare audience. The recall is registered as a Type II health product recall with identification number RA-82610.

Consumers and healthcare providers can find updates and further details by monitoring Health Canada’s recalls and safety alerts database, where the listing for this notice was last updated on September 9, 2026.