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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 August 29, 2006
Date Posted October 12, 2006
Recall Status1 Terminated 3 on January 22, 2007
Recall Number Z-0028-2007
Recall Event ID 36188
510(K)Number K011703  
Product Classification laser ablation - Product Code GEX
Product Lumenis brand DuoTome SideLite¿ 550 Micron Delivery System; laser systems for ablating soft tissue.
Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Code Information Lot/Batch Numbers:   37600206, 38030206, 38470206, 39110306, 39660406, 40480506, 41040506, 42110606, 42550706, 37640206, 38120206, 38480206, 39200306, 39670406, 40490506, 41050506, 42120606, 42560706, 37650206, 38150206, 38510206, 39210306, 39680406, 40520506, 41080506, 42200606, 42570706, 37660206, 38160206, 38520206, 39220306, 39690406, 40530506, 41090506, 42210606, 42580706, 37700206, 38170206, 38530206, 39240306, 39770406, 40570506, 41100506, 42280606, 42650706, 37710206, 38200206, 38700306, 39250306, 39800406, 40580506, 41210506, 42290606, 42680706, 37720206, 38210206, 38710306, 39260306, 39810406, 40590506, 41310506, 42300606, 42740706, 37730206, 38230206, 38720306, 39270306, 39820406, 40600506, 41360506, 42310606, 42810706, 37740206, 38240206, 38730306, 39280306, 39830406, 40610506, 41390506, 42320606, 42890706, 37750206, 38300206, 38740306, 39460306, 39840406, 40690506, 41450506, 42330606, 43000706, 37760206, 38310206, 38800306, 39470306, 39880406, 40710506, 41470506, 42350606, 43010706, 37770206, 38380206, 38810306, 39530306, 39890406, 40720506, 41500506, 42360606, 43060706, 37800206, 38390206, 38830306 39540306, 39900406, 40730506, 41610606, 42380606, 43150706, 37810206, 38400206, 38840306, 39550306, 40180406, 40930506, 41750606, 42410606, 43190706, 37820206, 38410206, 38920306, 39560306, 40200406, 40940506, 41880606, 42420606, 43200706, 37890206, 38420206, 38930306, 39570306, 40340406, 40960506, 41890606, 42430606, 43210706, 37910206, 38430206, 38970306 39580306, 40390406, 40970506, 41900606, 42460706, 43220706, 37960206, 38440206, 38980306, 39590306, 40430406, 40980506, 41930606, 42490706, 43270706, 37970206, 38450206, 38990306, 39600306, 40460506, 41020506, 41990606, 42500706, 43280706, 37980206, 38460206, 39000306, 39650306, 40470506, 41030506, 42000606, 42540706, 43410706
Recalling Firm/
Manufacturer		 Lumenis Inc.
2400 Condensa St
Santa Clara CA 95051-0901
For Additional Information Contact Ms. Lisa Scott
408-764-3303
Manufacturer Reason
for Recall		 Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.
FDA Determined
Cause 2		 Other
Action On 8/26/06, the firm initiated the recall and its notification was via letters and phone calls requesting return of affected product.
Quantity in Commerce 10,815
Distribution Worldwide, including USA, Japan, Europe, Hong Kong, Russia and Canada.
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 = LUMENIS
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