Public recall detail

Raystation 4-11b

medium
Recall Safety notice
Quick summary

Quick summary: Raystation 4-11b.

Recommended action

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Recall details

Quick summary: Raystation 4-11b.

Official details

Affected product details

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

BrandRaysearch Laboratories Ab [Publ]
ProductRaystation 4-11b
IssueMedical devices - Software defect
Recall classType II
IdentificationRA-63986

Affected products

ProductRaystation 4-11b
Lotversion 8.1.2, version 10.0.1, version 7.0.0
Model10B (10.1), 7, 8B, 10A (10.0)
Serial numberversion 8.1.2, version 10.0.1, version 7.0.0
DescriptionRaystation 4-11b

Issue

In rare cases, the SSD (source to skin or surface distance) calculation algorithm will miss the entry point of the ROI and instead calculate the distance to the exit point, resulting in an incorrect SSD. The SSD will be incorrect in UI, Dicom export, plan report, and scripting. If the bug is triggered when an intended SSD is entered in Raystation, the intended SSD will be displayed and exported, but the actual SSD of the plan is shorter than intended. Recall start date: Feb 11, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Radiology
CompaniesRaysearch Laboratories Ab (Publ) Sveavagen 44, Stockholm Sweden, 11134
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63986
Background{}
CompaniesRaysearch Laboratories Ab (Publ) Sveavagen 44, Stockholm Sweden, 11134
AudiencesGeneral public Health professionals Hospitals
Source updated2022-03-14

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

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