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Recall Observatory FDA recall evidence

Device product

RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system

Z-1463-2020

February 20, 2020

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 85065
Status
Terminated
Classification
Class II
Quantity
1 system in the U.S.
Official record key
device-enforcement:Z-1463-2020

Official wording

Reason: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

Code information: UDI 07350002010136

Distribution pattern: The products were distributed to the following US states: TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.