FDAFDA · Food and drugs·Recall number Z-1747-2024
RayStation 10.1.0.613 and 10.1.1.54. 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: 0735000201031020201216 and 0735000201047120220128; GTIN: 07350002010310 and 07350002010471; Serial Numbers: 10.1.0.613 and 10.1.1.54; Expiration Date: 2027-02-01.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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