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Health Canada Medical devices

3mensio Workstation

Issued July 17, 2025
Issue
Incorrect visualization of clock positions in the fenstration diagram (vascular -fenestrated workflow) may potentially lead to harm of the patient. Users will be informed with a letter in which instructions are provided how to prevent the issue. A new software version will be delivered in which the defect will not occur. Recall start date: July 8, 2025
Hazard description
Performance
Product
Product name
3mensio Workstation
Reference
ID
RA-77737