Devices

Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan

Model / Serial
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
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
Manufacturer
RAYSEARCH LABORATORIES AB
1 Event
- Recall of Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan

Manufacturer

RAYSEARCH LABORATORIES AB

Manufacturer Address
RAYSEARCH LABORATORIES AB, Sveavaegen 9, Stockholm Sweden
Manufacturer Parent Company (2017)
Raysearch Laboratories Ab (Publ)
Source
USFDA

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