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Terminated

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

FDA Recall Z-1598-2021 · Posted None

Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2021-04-07
Date Terminated2023-06-02

Reason for Recall

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.

Firm Action

On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.

Root Cause

Software design

Distribution Pattern

Domestic: TN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200569RayStationRaySearch Laboratories AB (PUBL) · 2020-09-24

Official Source

View FDA Recall →

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

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