CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
RayStation 1.0.47 recalled by Raysearch Laboratories Ab
Raysearch Laboratories Ab is recalling RayStation 1.0.47, 1.1.8 and 1.2.5, distributed nationwide in the US. The recall was initiated on 28 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1743-2024
- FDA event ID
- 94388
- Recalling firm
- Raysearch Laboratories Ab, Stockholm
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Mar 2024
- FDA classified
- 1 May 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Mar 2024 | Recall initiated by company | |
| 1 May 2024 | Classified by FDA | +34 days |
| 8 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for reported SSD to be too high.
Product as listed by the FDA
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
Questions about this recall
Is RayStation 1.0.47, 1.1.8 and 1.2.5 recalled?
Yes. Raysearch Laboratories Ab recalled RayStation 1.0.47, 1.1.8 and 1.2.5 on 28 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1743-2024.
Why was it recalled?
Potential for reported SSD to be too high.
Which lots are affected?
UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10; Expiration Date: 2024-06-05.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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