Public recall detail

Hybrid Recon 4.0 and 5.0

2024-11-14

medium
Recall Safety notice
Quick summary

Quick summary: Hybrid Recon 4.0 and 5.0. Date: 2024-11-14.

Recommended action

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

Recall details

Quick summary: Hybrid Recon 4.0 and 5.0. Date: 2024-11-14.

Official details

Affected product details

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

BrandHermes Medical Solutions, Ab
ProductHybrid Recon 4.0 and 5.0
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76498

Affected products

ProductHybrid Recon 4.0
Lotversion 4.0.x*
Model00859873006158
Serial numberversion 4.0.x*
DescriptionHybrid Recon 4.0
ProductHybrid Recon 5.0
Lotversion 5.0.0
ModelVERSION 5.0
Serial numberversion 5.0.0
DescriptionHybrid Recon 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

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 Health products - Medical devices - Radiology
CompaniesHermes Medical Solutions, Ab Strandbergsgatan 16, Stockholm, Sweden, 11251
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76498
Background{}
CompaniesHermes Medical Solutions, Ab Strandbergsgatan 16, Stockholm, Sweden, 11251
AudiencesHealthcare Industry
Source updated2024-11-14

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

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