RAYSEARCH LABORATORIES AB: RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.

Hazard

Potential for reported SSD to be too high.

Details from the source

Reason for recall: Potential for reported SSD to be too high. Distribution: 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, T Quantity: 63 units Lot/code info: UDI: 0735000201017420190612 and 0735000201048820220420; GTIN: 07350002010174 and 07350002010488; Serial Numbers: 9.0.0.113 and 9.0.1.142; Expiration Date: 2027-12-15.

UPC codes

07350002010174, 07350002010488

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.