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Terminated

RayStation 9B SP1. For radiation treatment planning.

FDA Recall Z-1403-2022 · Posted None

Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2022-06-01
Date Terminated2023-10-04
Product Quantity1

Reason for Recall

An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

Firm Action

The firm contacted all customers via email on June 1, 2022. Customers were provided with a list of workflows where safety related information may not be propagated. Customers were instructed to be aware that treatment course information in RayCare may not always be up to date. Customers should verify critical information in RayStation or RayTreat before treatment course information in RayCare is used for critical decisions. Customers were asked to identify all installed units with the affected software version numbers. The issue will be resolved in mandatory software updates for RayStation, scheduled for market release in June 2022.

Root Cause

Software change control

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.

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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