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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 62967
Product Type Devices
Status Ongoing
City Stockholm
Country SE
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-09
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are and Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. Software version and build numbers are and Product lifetime is 5 years. Class II The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5, Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimization of segment shapes and allowing for optimization of segment Monitor Units. As a result, the dose calculation may be incorrect by a factor of 3-6. The result is always an underestimation of the dose, potentially leading to over-dosage of the patient as MU values are increased to compensate. 19 units Z-2324-2012