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U.S. Department of Health and Human Services

Class 2 Device Recall XTEN LED Video DF cupola

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 Class 2 Recall
XTEN LED Video DF cupola
see related information
Date Posted November 12, 2009
Recall Status1 Terminated on June 04, 2012
Recall Number Z-0187-2010
Recall Event ID 53499
Premarket Notification
510(K) Number
Product Classification Light, Surgical, Ceiling Mounted - Product Code FSY
Product XTEN LED Video DF cupola, P/N: 567801999. Intended to provide visible illumination for the surgical field or for the examination of the patient.
Code Information Part Number: 567801999
Recalling Firm/
1140 Us Highway 22 Ste 202
Bridgewater, New Jersey 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.
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 331
Distribution Nationwide Distribution.
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
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = ALM S.A.