Reported May 8, 2024 · Ongoing
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Raysearch Laboratories Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RAYSEARCH LABORATORIES AB · Eugeniavagen 18c · Stockholm · N/A
Is this the product you have?
- RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
- Lot codes and dates
- UDI0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222
- GTIN
07350002010426073500020104950735000201050107350002010600 and 07350002010570
- Serial Numbers
12.0.0.93212.1.0.122112.0.3.6812.0.4.12 and 12.3.0.119
- Expiration Date2028-03-20
- Amount recalled
- 66 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential for reported SSD to be too high.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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