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Recall Observatory FDA recall evidence

Device product

RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.

Z-1742-2024

March 28, 2024

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 94388
Status
Ongoing
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-1742-2024

Official wording

Reason: Potential for reported SSD to be too high.

Code information: 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.

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.