RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
FDA Recall Z-1308-2014 · Posted 2014-03-31
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Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2014-02-06
Date Terminated2017-02-17
Product Quantity19 units (16 units domestically & 3 units internationally)
Reason for Recall
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Firm Action
On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases.
For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or [email protected].
Root Cause
Software Design Change
Distribution Pattern
OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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