PlainRecalls
FDA Devices Moderate Class II Terminated

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Reported: June 25, 2014 Initiated: April 25, 2014 #Z-1806-2014

Product Description

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Reason for Recall

This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.

Details

Recalling Firm
RAYSEARCH LABORATORIES AB
Units Affected
25 sites/245 units (US), 25 sites/124 units (foreign)
Distribution
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
Location
Stockholm, N/A

Frequently Asked Questions

What product was recalled? ▼
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 25 sites/245 units (US), 25 sites/124 units (foreign).
Why was this product recalled? ▼
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2014. Severity: Moderate. Recall number: Z-1806-2014.

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