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Terminated

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

FDA Recall Z-0281-2014 · Posted 2013-11-14

Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2013-10-23
Date Terminated2017-02-17
Product Quantity195 units domestically

Reason for Recall

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.

Firm Action

Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130617RAYSTATIONRaysearch Laboratories AB · 2013-05-10K120387RAYSTATIONRaysearch Laboratories AB · 2012-04-06

Official Source

View FDA Recall →

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

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