Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The product affected by this notice is sold under the Recalled by RAYSEARCH LABORATORIES AB Due to This field notice concerns two behaviors of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact RAYSEARCH LABORATORIES AB directly.
Affected Products
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
Quantity: 15 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 6 states: CA, KY, MI, NY, OK, OR
About RAYSEARCH LABORATORIES AB
RAYSEARCH LABORATORIES AB has 113 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report