CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy recalled
Raysearch Laboratories AB is recalling RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy, 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-1746-2024
- 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 10.0.0.1154, 10.0.1.52 & 10.0.2.10. 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
Why was it recalled?
Potential for reported SSD to be too high.
Which lots are affected?
UDI: 0735000201030320200526, 0735000201036520200526 and 0735000201065520220608; GTIN: 07350002010303, 07350002010365 and 07350002010655; Serial Numbers: 10.0.0.1154, 10.0.1.52 and 10.0.2.10; Expiration Date: 2025-06-16.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 94388This product is part of a recall event; the main page for the event is RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy recalled.
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