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Recall Observatory FDA recall evidence

Device product

RayStation 9B SP1. For radiation treatment planning.

Z-1403-2022

June 01, 2022

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 90498
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1403-2022

Official wording

Reason: An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

Code information: UDI-DI: 0735000201029720200310 Build number 9.2.0.483

Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.