Health product recall

Raystation 4-11b

Last updated

Summary

Product
Raystation 4-11b
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Raystation 4-11b

version 8.1.2, version 10.0.1, version 7.0.0

10B (10.1), 7, 8B, 10A (10.0)

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

Additional information

Details
Original published date: 2022-03-17
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Raysearch Laboratories Ab (Publ)

Sveavagen 44, Stockholm

Sweden, 11134

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63986