3mensio Workstation
Brand(s)
Last updated
Summary
Product
3mensio Workstation
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| 3mensio Workstation | Not applicable. | 10.6 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Pie Medical Imaging B.V.
Philipsweg 1, Maastricht, Netherlands, 6227 AJ
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-77737
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