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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65136
Product Type Devices
Status Ongoing
City Stockholm
Country SE
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA including Connecticut, Florida, Massachusetts, Missouri, New York, Ohio, and foreign distribution to(Canada, Italy, Australia, Germany, Netherlands, and Switzerland.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy. Software version and build numbers,, and (to determine if the version used is affected, bring up the About box in the RayStation application and check the build number reported0. Class II Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning. Domestic: 70 units; Foreign: 27 units Z-1419-2013