RAYSEARCH LABORATORIES AB: Medical Device Recall in 2012 - (Recall #: Z-2444-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 10, 2011

Date Posted: October 3, 2012

Recall Number: Z-2444-2012

Event ID: 63186

Reason for Recall:

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)

Status: Terminated

Product Quantity: 20 units

Code Information:

version 1.2.1 (build number 1.3.1.10).

Distribution Pattern:

Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated