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U.S. Department of Health and Human Services

Class 2 Device Recall Light Source, Endoscopic, Xenon Arc

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 Class 2 Device Recall Light Source, Endoscopic, Xenon Arcsee related information
Date Initiated by FirmMay 20, 2011
Date PostedSeptember 25, 2012
Recall Status1 Terminated 3 on September 26, 2012
Recall NumberZ-2456-2012
Recall Event ID 63009
510(K)NumberK070376 
Product Classification Light source, endoscope, xenon arc - Product Code GCT
Product***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
Code Information GCT
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information ContactRoger Murphy
727-399-5202
Manufacturer Reason
for Recall		Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionLinvatec Corporation sent an "URGENT Medical Device Recall Notification letter dated May 20, 2011 to its customers via FedEx service. Firm advised their suppliers of the Light Sources potentially has unapproved components and does not meet the finished product requirement. The distributors and end user level are advised if any affected product is in their possession can be used until returned for advance exchange. The customers were instructed to: 1) locate the identified product by serial number at your facility and complete the Reply Form attached; 2) Contact ConMed Linvatec Customer Service (800-237-0169) to receive SR Number Advance Exchange affected product only. Once Customer Service authorizes the SR Number your Advance Exchange Light Source will be shipped to your facility; 3) Once replacement unit is received, utilize the packaging material to return the recalled Light Source to ConMed Linvatec using the enclosed FedEx Airway Bill. Mail or FAX copy of Reply Form to ConMed Linvatec; 4) Complete and return a copy of the Reply Form. For questions contact your local ConMed Linvatec office or email Custseryl@linvatec.com, Customer Service at 800-237-0169 or fax to 727-319-5701.
Quantity in Commerce57
DistributionWorldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GCT
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