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Recall Observatory FDA recall evidence

Device product

RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

Z-1598-2021

April 07, 2021

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 87868
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1598-2021

Official wording

Reason: When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

Code information: Software version number: 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 , 10.1.0.613

Distribution pattern: Domestic: TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.