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U.S. Department of Health and Human Services

Class 2 Device Recall ILED Surgical Light

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  Class 2 Device Recall ILED Surgical Light see related information
Date Initiated by Firm February 27, 2009
Date Posted April 01, 2009
Recall Status1 Terminated 3 on October 22, 2009
Recall Number Z-1122-2009
Recall Event ID 51236
510(K)Number K061317  
Product Classification Ceiling Mounted Surgical Light - Product Code FSY
Product ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
Code Information Serial numbers: 100268621 to 100717475
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
415 Jessen Ln
Charleston SC 29492
For Additional Information Contact Lindsey Hengel
843-474-9359
Manufacturer Reason
for Recall		 Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.
FDA Determined
Cause 2		 Other
Action Consignees were notified via an Urgent Safety Information letter starting 02/27/2009. The Recall Notice asks customers to visually inspect the ILED covers for cracks and in particular to focus on the corners. If cracking is visible they are asked to remedy by taping with a clear tape over the cracks and report it to TRUMPF Medical Systems, Inc. immediately. TRUMPF will be replacing all covers with a newly designed and tested cover. Original priority in the United States will be set to start with the oldest units affected. If TRUMPF receives notification that cracking does exist then that facility will rise to the highest priority. Additionally, TRUMPF will issue a new approved cleaning and disinfection instruction, since investigations have shown that the cracking is significantly influenced by the use of certain disinfectants containing alcohol. The operator manual previously stated to avoid using alcohol-based cleaners on some parts of the ILED, but after reviewing this it was determined that it was not clearly stated to avoid use on the covers.
Quantity in Commerce 4480 units (540 in U.S.)
Distribution Worldwide Distribution.
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 KREUZER MEDIZIN SYSTEME GMBH + CO.KG
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