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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description 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.
Recall Number Z-1402-2013
Classification Class II
Code Info 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
Product Distributed Qty 31
Reason For Recall Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.

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
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