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U.S. Department of Health and Human Services

Class 2 Device Recall Helion S Exam Light or H300

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 Class 2 Recall
Helion S Exam Light or H300
see related information
Date Posted December 12, 2013
Recall Status1 Open
Recall Number Z-0484-2014
Recall Event ID 66790
Premarket Notification
510(K) Number
K011693 
Product Classification Light, Surgical, Ceiling Mounted - Product Code FSY
Product Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
Code Information Unknown
Recalling Firm/
Manufacturer
Trumpf Medical Systems, Inc.
415 Jessen Ln
Charleston, South Carolina 29492-7906
For Additional Information Contact Lindsey Ronnenberg
888-474-9359
Manufacturer Reason
for Recall
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action TRUMPF sent an Urgent Recall Notice dated February 19, 2013, to all US affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The recall notice instructed customers to verify if they still have these light systems, and if they do have the light system verify if they have a metal or plastic ring at the joint of concern (per the manufacturer's Safety Notice). TRUMPF will directly work with affected customers to replace the affected arm system. For further questions please call ( 888 ) 474-9359.
Quantity in Commerce 287
Distribution US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = TRUMPF MEDICAL SYSTEMS, INC.
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