Recall Z-2444-2012— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-2444-2012
Creator: U.S. Food and Drug Administration
Published: 2011-10-10

Class II · Terminated

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2011-10-10, terminated 2013-01-25. It names one FDA 510(k) clearance: K083264. 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.. 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).

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Terminated
Initiated: 2011-10-10
Terminated: 2013-01-25
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K083264 — RAYAUTOPLAN 1.0Raysearch Laboratories AB·cleared 2009-01-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.