RAYSEARCH LABORATORIES AB: Medical Device Recall in 2012 - (Recall #: Z-2378-2012)

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:

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

Product Classification:

Class II

Date Initiated: May 30, 2011

Date Posted: September 26, 2012

Recall Number: Z-2378-2012

Event ID: 63110

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

Status: Terminated

Product Quantity: 15 units

Code Information:

SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated