RAYSEARCH LABORATORIES AB: RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. 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: 10 units Lot/code info: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616; GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631; Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15; Expiration Date: 2027-06-22.

UPC codes

07350002010389, 07350002010433, 07350002010440, 07350002010631

Source

Official record: FDA (Device enforcement) ↗

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