Company:RAYSEARCH LABORATORIES AB
Date of Enforcement Report 9/26/12
Class ll:
PRODUCT
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.Recall Number Z-2444-2012
REASON
This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc). In such cases, special notice has to be taken of the coordinate system used. The correction is to modify the labelling.
RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm Sweden on 10/10/11. Voluntary: Firm Initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide and Internationally
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