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Recall Observatory FDA recall evidence

Device product

RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.

Z-1748-2024

March 28, 2024

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 94388
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-1748-2024

Official wording

Reason: Potential for reported SSD to be too high.

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for reported SSD to be too high.