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Recall Observatory FDA recall evidence

Device product

Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

Z-2785-2015

May 29, 2015

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 71477
Status
Terminated
Classification
Class II
Quantity
20 devices
Official record key
device-enforcement:Z-2785-2015

Official wording

Reason: An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images

Code information: software build numbers are 4.7.0.15 or 4.7.1.10

Distribution pattern: Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images