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U.S. Department of Health and Human Services

Class 2 Device Recall XTEN LED DF cupola

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  Class 2 Device Recall XTEN LED DF cupola see related information
Date Initiated by Firm October 07, 2009
Date Posting Updated November 12, 2009
Recall Status1 Terminated 3 on June 04, 2012
Recall Number Z-0188-2010
Recall Event ID 53499
510(K)Number K040735  
Product Classification Surgical Ceiling Mounted Light - Product Code FSY
Product XTEN LED DF cupola, P/N: 567815999.

Intended to provide visible illumination for the surgical field or for the examination of the patient.
Code Information Part Number: 567815999.
Recalling Firm/
1140 Us Highway 22 Ste 202
Bridgewater NJ 08807-2958
For Additional Information Contact Jamie Yieh
Manufacturer Reason
for Recall
Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.
FDA Determined
Cause 2
Device Design
Action Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative.
Quantity in Commerce 346
Distribution Nationwide 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 = ALM S.A.