CFIA - Canadian Food Inspection Agency
CFIA - Canadian Food Inspection Agency
09/09/2026 | Press release | Distributed by Public on 09/09/2026 12:20
Veradius Unity and BV Pulsera Mobile C-Arm System-9in. and 12in. Versions
Health product recall
Veradius Unity and BV Pulsera Mobile C-Arm System-9in. and 12in. Versions
Last updated
2026-09-09
Summary
Product
Veradius Unity and BV Pulsera Mobile C-Arm System-9in. and 12in. Versions
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
|
Affected products |
Lot or serial number |
Model or catalogue number |
|
Veradius Unity |
Not applicable. |
718132 |
|
BV Pulsera Mobile C-Arm System-9in. And 12in. Versions |
Not applicable. |
718095 |
Issue
Air bubbles may develop in the monoblock oil when there is a prolonged period between manufacture and installation, for example due to storage, transportation, or other pre-installation holding time. During a clinical procedure, when the user activates X-ray imaging, if an air bubble becomes trapped in the high-voltage area of the monoblock, there could be an internal electrical discharge (flashover) resulting in X-rays not being generated and consequently no image being displayed on the examination monitor. When this situation occurs, the system displays an error message indicating that the X-ray generator is not available. In some cases, restarting the system (which takes approximately 5 minutes) may restore X-ray generation. Philips' investigation indicates that this issue may occur during the early period of system use following a prolonged period between manufacture and installation. Based on the investigation, potentially affected systems have been identified as those for which more than 300 days elapsed between manufacture and installation and fewer than 250 days have elapsed since installation with continued system use, the monoblock oil temperature increases, allowing storage-related air bubbles to gradually dissipate over time.
Additional information
Details
Original published date: 2026-09-09
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
| Philips Medical Systems Nederland B.V. |
| Veenpluis 6, Best, Netherlands, 5684 PC |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
2026-09-01
Identification number
RA-82610
Get notified
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Date modified: 2026-09-09
CFIA - Canadian Food Inspection Agency published this content on September 09, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on September 09, 2026 at 18:20 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]