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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 65060
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Atlanta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-30
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. 325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269, 325129, 325296, 325273, 325139, 325201, 325137, 325184, 325161, 325076, 325086, 325112, 325081, 325083, 325099, 325110, 325271 Class II Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0. 31 Z-1402-2013
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