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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Event Detail

Event ID 63255
Product Type Devices
Status Ongoing
Recalling Firm Trumpf Medical Systems, Inc.
City Charleston
State SC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number). Class II Incidents regarding fractures of the front joint of the spring arm have been reported. 275 units Z-0077-2013