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Recall Observatory FDA recall evidence

Device product

RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.

Z-1749-2024

March 28, 2024

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 94388
Status
Ongoing
Classification
Class II
Quantity
66 units
Official record key
device-enforcement:Z-1749-2024

Official wording

Reason: Potential for reported SSD to be too high.

Code information: UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222; GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570; Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119; Expiration Date: 2028-03-20.

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.