Raystation
Press Release
By:
Ref: Health Canada
Published: 03/08/2024
Raystation - Canada.ca
Health product recall
Brand(s)
Last updated
2024-03-08
Product
Raystation
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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| 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 |
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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
Details
Original published date:
2024-03-08
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