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U.S. Department of Health and Human Services

Class 2 Device Recall Lumenis

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  Class 2 Device Recall Lumenis see related information
Date Initiated by Firm February 01, 2006
Date Posted March 02, 2006
Recall Status1 Terminated 3 on December 21, 2006
Recall Number Z-0545-06
Recall Event ID 34525
510(K)Number K913569  K990179  
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems;
Manufactured before November 4, 2003;

Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104
Code Information All codes manufactured prior to November 4, 2003.
Recalling Firm/
Manufacturer		 Lumenis Inc.
2400 Condensa St
Santa Clara CA 95051-0901
For Additional Information Contact Ms. Connie Hoy
408-764-3303
Manufacturer Reason
for Recall		 The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.
FDA Determined
Cause 2		 Other
Action On 7/26/04 and 2/1/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned for correction.
Quantity in Commerce Approx. 1436 units
Distribution Nationwide. The product was released for distribution to 1431 consignees worldwide. International consignees include: Australia, Canada, India, Netherlands, Argentina, France, Malaysia, Italy, Brazil, Mexico, China, Colombia, Thailand, Holland, Japan, and Venezuela. There were no shipments to U.S. Government facilities or foreign or Canadian 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 = GEX and Original Applicant = HGM MEDICAL LASER SYSTEMS, INC.
510(K)s with Product Code = GEX and Original Applicant = NORTRADE MEDICAL, INC.
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