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U.S. Department of Health and Human Services

Class 2 Device Recall Helion and Xenion surgical lights

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  Class 2 Device Recall Helion and Xenion surgical lights see related information
Date Initiated by Firm September 19, 2012
Date Posted October 18, 2012
Recall Status1 Terminated 3 on January 21, 2014
Recall Number Z-0077-2013
Recall Event ID 63255
510(K)Number K011693  
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product 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.
Code Information 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).
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
415 Jessen Ln
Charleston SC 29492
For Additional Information Contact Lindsey Ronnenberg
843-534-0606
Manufacturer Reason
for Recall		 Incidents regarding fractures of the front joint of the spring arm have been reported.
FDA Determined
Cause 2		 Device Design
Action Trumpf sent an "URGENT RECALL NOTICE" dated September 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Confirmation of Receipt Form was attached for customers to complete and return. Contact the firm at 888-474-9359 for questions regarding this notice.
Quantity in Commerce 275 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = TRUMPF MEDICAL SYSTEMS, INC.
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