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Terminated

RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy

FDA Recall Z-1930-2019 · Posted None

Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2017-11-20
Date Terminated2023-08-08
Product Quantity744

Reason for Recall

When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong

Firm Action

RaySearch issued Field Safety Notice, Medical Device Correction #24138 via email on November 20th, 2017. The letter identifies the product, issue, health risk and action to take: Do not use a number of histories above 6 million for electron dose calculation. Inspect all commissioned electron beam models for any applicator calculated with greater than 6 million. Contact customer support if you have any further questions. Confirm you have read and understood this notice. This issue will be resolved in the next version of RayStation, scheduled for market release in December 2017. Educate planning staff and all users about this workaround.

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171536RayStationRaySearch Laboratories AB (PUBL) · 2017-06-27

Official Source

View FDA Recall →

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

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