RAYSEARCH LABORATORIES AB: RayStation 9.1.0.933 and 9.2.0.483. 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: 11 units Lot/code info: UDI: 0735000201026620191220 and 0735000201029720200310; GTIN: 07350002010266 and 07350002010297; Serial Numbers: 9.1.0.933 and 9.2.0.483; Expiration Date: 2025-03-31.

UPC codes

07350002010266, 07350002010297

Source

Official record: FDA (Device enforcement) ↗

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