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U.S. Department of Health and Human Services

Class 2 Device Recall Trumpf Medical

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  Class 2 Device Recall Trumpf Medical see related information
Date Initiated by Firm November 02, 2015
Create Date December 31, 2015
Recall Status1 Completed
Recall Number Z-0563-2016
Recall Event ID 72542
510(K)Number K102758  K061317  
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Code Information 4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
1046 Legrand Blvd
Charleston SC 29492-7672
For Additional Information Contact Chandler Sprinkles
843-329-0543
Manufacturer Reason
for Recall		 The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
FDA Determined
Cause 2		 Other
Action TRUMPF sent an " Urgent Field Safety Information" letter dated December 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the customer: 1. Perform an inspection of the lighting systems (see Appendix 1 for instructions). If any of the symptoms listed below are observed, immediately remove the light from operation and contact your Trumpf Medical Service Representative or designee. Signs that indicate a possible fall of the spring arm: The movement of the light and spring arm is difficult for the user, The lights have stopped being operational, and/or A gap is noticed between the spring arm and the central axis (see the attached Appendix 1 for an example). 2. Follow the User Manual: No unauthorized servicing of the spring arm is permitted. Snap rings are one use only and replacements must be purchased from your authorized Trumpf Medical partner. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359
Quantity in Commerce 20,713
Distribution USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.
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.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG
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