Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Drager Surgical Lights Sola 500 and Sola 700

  • 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 Drager Surgical Lights Sola 500 and Sola 700 see related information
Date Initiated by Firm August 26, 2009
Date Posted September 16, 2009
Recall Status1 Terminated 3 on March 08, 2010
Recall Number Z-2212-2009
Recall Event ID 53135
510(K)Number K010724  
Product Classification Lamp, surgical - Product Code FTD
Product Drager Surgical Lights Sola 500 and Sola 700.
Code Information All product with Catalog Number: 4115571.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael Kelhart
800-543-5047
Manufacturer Reason
for Recall		 welded seam may fail
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Draeger Medical, Inc. issued a "Medical Device Recall" letter dated August 2009 via certified mail with return receipt. Consignees were informed on the affected product and that a service representative will be in contact shortly to schedule a replacement. For further information, contact Draeger Medical at 1-800-543-5047, press 1 at the prompt and then 2349.
Quantity in Commerce 20 units
Distribution Nationwide Distribution -- IL, KY, and PA.
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 = FTD and Original Applicant = DRAGER MEDIZINTECHNIK GMBH
-
-