The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To ...
FDA Recall #Z-2378-2012 — Class II — May 30, 2011
Product Description
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10 . 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
Reason for Recall
This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have 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 delivere
Recalling Firm
RAYSEARCH LABORATORIES AB — Stockholm
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15 units
Distribution
Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
Code Information
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated