RAYSEARCH LABORATORIES AB: RayStation 8.0.0.61, 8.0.1.10. 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: 9 units Lot/code info: UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10 Software Revisions: RayStation/RayPlan 8A and 8A Service Pack 1; Expiration Date: 2023-10-04.

UPC codes

07350002010112, 07350002010136

Source

Official record: FDA (Device enforcement) ↗

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