RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. [email protected] Designed for treatment planning and analysis of radiation therapy.
FDA Recall Z-1317-2012 · Posted 2012-03-26
Recalling FirmRAYSEARCH LABORATORIES AB
Recall StatusTerminated
Product CodeMUJ
Date Initiated2011-12-06
Date Terminated2012-05-11
Product Quantity21 units (16 domestically and 5 internationally)
Reason for Recall
An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.
Firm Action
The firm decided to recall and sent Urgent Field Safety Notice Medical Device Correction letters to consignees on 12/06/2011. The letters described the issue, identified the affected product, actions to be taken by the user, a solution, and contact information. Users are to follow the two part workaround, and educate their staff and all users on the workarounds. The letter states that the issue will be resolved in the next version of RayStation. If further information is needed, users are to contact either Freddie Cardel, Director of Customer Support, RaySearch Americas, at 1-877-778-3849 or [email protected]; or Niclas Borglund, Director of Service, RaySearch Laboratories AB, at 46-8-5450-6130 or [email protected]
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- US, including the states of FL, MA, NJ, and NY and the country of the Netherlands.
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.