Health product recall

Raystation

Last updated

Summary

Product
Raystation
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Raystation

version 8.1.0.47
version 12.0.0.932
version 10.0.1.52
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

11B SP3
10A SP1
10B SP1
11B SP1

Issue

This recall concerns a use error that has occurred with Raystation, where material override using silicon, SI, was incorrectly selected for a silicone gel polymer implant.

Recall start date: February 23, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Raysearch Laboratories Ab (Publ)
Eugeniavagen 18c, Stockholm, Sweden, 11368
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75202

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