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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Drager Surgical Lights Sola 500 and Sola 700
see related information
Date Posted September 16, 2009
Recall Status1 Terminated on March 08, 2010
Recall Number Z-2212-2009
Recall Event ID 53135
Premarket Notification
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, Pennsylvania 18969-1042
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Michael Kelhart
800-543-5047
Manufacturer Reason
for Recall
welded seam may fail
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 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 = DRAGER MEDIZINTECHNIK GMBH
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