Public recall detail

3mensio Workstation

2025-07-17

medium
Recall Safety notice
Quick summary

Quick summary: 3mensio Workstation. Date: 2025-07-17.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: 3mensio Workstation. Date: 2025-07-17.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandPie Medical Imaging B.V.
Product3mensio Workstation
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77737

Affected products

Product3mensio Workstation
LotNot applicable.
Model10.6
Serial numberNot applicable.
Description3mensio Workstation

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesPie Medical Imaging B.V. Philipsweg 1, Maastricht, Netherlands, 6227 AJ
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77737
Background{}
CompaniesPie Medical Imaging B.V. Philipsweg 1, Maastricht, Netherlands, 6227 AJ
AudiencesHealthcare Industry
Source updated2025-07-17

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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