FDAFDA · Food and drugs·Recall number Z-1746-2024
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Published May 8, 2024 · Recall initiated: March 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for reported SSD to be too high.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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