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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

Product Description Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Recall Number Z-0281-2014
Classification Class II
Code Info Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.
Product Distributed Qty 195 units domestically
Reason For Recall Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

Event Detail

Event Id 66600
Product Type Devices
Status Ongoing
Recalling Firm RAYSEARCH LABORATORIES AB
City Stockholm
State
Country SE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-23
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia
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