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Terminated

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.

FDA Recall Z-0294-2019 · Posted None

Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2018-09-21
Date Terminated2020-06-16
Product Quantity110 units

Reason for Recall

Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.

Firm Action

Ray Search Labs notified userson 9/21/18 by email advising users of the action to be taken: After creating an adaptive plan from a plan with robust objectives, remove all robust objectives that are automatically added to the adaptive plan and replace them with other appropriate objectives before optimizing the adapted plan. o Do not use an optimization function template with robust functions for a dependent beam set.o Do not use scripting to add robust optimization functions related to beam set + background dose. Reply form to be completed/signed and returned. Regulatory information, please contact [email protected]

Root Cause

Software design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180379RayStation 7RaySearch Laboratories AB (PUBL) · 2018-04-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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