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Terminated

RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.

FDA Recall Z-1307-2014 · Posted 2014-03-28

Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-02-06
Date Terminated2017-02-17
Product Quantity151 units Total (88 units domestically & 63 units internationally)

Reason for Recall

Potential for dose errors due to software program errors.

Firm Action

RaySearch Laboratories sent an Field Safety Notice, Medical Device Correction letter dated February 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. ACTIONS TO BE TAKEN BY THE USER A workaround that eliminates the described error is to select the discard rotations option in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. Another option is to use the ROI based deformable registration when applicable, as this functionality is not affected by the error. SOLUTION This issue will be resolved in a patch release of RayStation, scheduled for market release February 28, 2014. Release schedule is subject to regulatory approval for some markets. In the meantime, this field safety notice is being distributed to all customers. CONTACT INFORMATION For further information, please contact For the Americas: Customer Support, RaySearch Americas, at +1 877 778 3849 For Europe, Asia and rest of the world: RaySearch Laboratories AB, at +46 8 5450 6130 Thank you for your cooperation, and we apologize for any inconvenience

Root Cause

Software Design Change

Distribution Pattern

Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130617RAYSTATIONRaysearch Laboratories AB · 2013-05-10K120387RAYSTATIONRaysearch Laboratories AB · 2012-04-06K100552RAYSTATION VERSION 1.0Raysearch Laboratories AB · 2010-03-12

Official Source

View FDA Recall →

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

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