• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HANAULUX 2004 IXL cupola

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
 Class 2 Device Recall HANAULUX 2004 IXL cupola see related information
Date Posted November 12, 2009
Recall Status1 Terminated on June 04, 2012
Recall Number Z-0182-2010
Recall Event ID 53499
510(K)Number K895715 
Product Classification Surgical Lamp - Product Code FTD
Product HANAULUX 2004 IXL cupola, P/N: 56076868

Intended to provide visible illumination for the surgical field or for the examination of the patient.
Code Information Part Number: 56076868 - all serial numbers
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 3
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
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 = FTD and Original Applicant = W.C. HERAEUS GMBH