Health product recall

Hybrid Recon 4.0 and 5.0

Last updated

Summary

Product
Hybrid Recon 4.0 and 5.0
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 catalogue number
Hybrid Recon 4.0 version 4.0.x* 00859873006158
Hybrid Recon 5.0 version 5.0.0 VERSION 5.0

Issue

When reconstructing aspect/CT study, in some cases, the aspect and CT series are not correctly aligned. Normally, the hybrid recon application warns the user if the frames of reference do not match, however in some configurations this warning message may be turned off.

Recall start date: October 31, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - Radiology
Companies
Hermes Medical Solutions, Ab
Strandbergsgatan 16, Stockholm, Sweden, 11251
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-76498

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