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Recall Observatory FDA recall evidence

Device product

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

Z-0281-2014

October 23, 2013

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 66600
Status
Terminated
Classification
Class II
Quantity
195 units domestically
Official record key
device-enforcement:Z-0281-2014

Official wording

Reason: Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

Code information: Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.

Distribution pattern: US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.