Public recall detail

RayStation

2024-04-11

medium
Recall Safety notice
Quick summary

Quick summary: RayStation. Date: 2024-04-11.

Recommended action

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

Recall details

Quick summary: RayStation. Date: 2024-04-11.

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
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75384

Affected products

ProductRayStation
Lotversion 8.1.0.47 version 12.0.0.932 version 10.0.1.52 version 7.0.0 version 12.0.4.12 version 10.1.0.613 version 12.1.0.1221 version 10.1.1.54 version 8.1.2.5
Model11B SP3 10A SP1 10B SP1 11B SP1
Serial numberversion 8.1.0.47 version 12.0.0.932 version 10.0.1.52 version 7.0.0 version 12.0.4.12 version 10.1.0.613 version 12.1.0.1221 version 10.1.1.54 version 8.1.2.5
DescriptionRayStation

Issue

An issue was found with the calculation of the reported SSD (i.e., the SSD displayed and exported) in RayStation RayPlan 7-2024a including some service packs. The reported SSD may in very rare cases be too high. The dose calculation is not affected by this issue. Recall start date: February 23, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesRaysearch Laboratories Ab (Publ) Eugeniavagen 18c, Stockholm, Sweden, 11368
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75384
Background{}
CompaniesRaysearch Laboratories Ab (Publ) Eugeniavagen 18c, Stockholm, Sweden, 11368
AudiencesHealthcare
Source updated2024-04-11

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

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