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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Product Detail

Product Description Monaco RTP System Radiation treatment planning
Recall Number Z-2276-2013
Classification Class II
Code Info Versions 3.10.00 and later
Product Distributed Qty 45
Reason For Recall Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

Event Detail

Event Id 65996
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Atlanta
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.