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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

Product Description DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Recall Number Z-2157-2013
Classification Class II
Code Info EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046
Product Distributed Qty 31
Reason For Recall Clinical mistreatment may occur when there are errors in the clinical work flow.

Event Detail

Event Id 66048
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Atlanta
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.