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U.S. Department of Health and Human Services

Class 2 Device Recall ENDOSCOPIC Camera

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  Class 2 Device Recall ENDOSCOPIC Camera see related information
Date Initiated by Firm September 23, 2011
Date Posted October 21, 2011
Recall Status1 Terminated 3 on February 16, 2016
Recall Number Z-0082-2012
Recall Event ID 60054
510(K)Number K014158  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Smith & Nephew, HD1200 Autoclavable Camera Head
Catalog Number: 72203360

Product Usage: Endoscope & Accessories
Code Information S/N: DDQ00051, DDQ00052, DDQ00057 DDQ00064, DDQ00068, DDQ00070 DDQ00071, DDQ00080, DDQ00083 DDQ00085, DDQ00093, DDQ00094 DDQ00096, DDQ00104, DDQ00108
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact
978-749-1073
Manufacturer Reason
for Recall		 HD1200 camera heads may cause image issues
FDA Determined
Cause 2		 Process design
Action Smith Nephew sent an "URGENT  PRODUCT RECALL NOTIFICATION" letter dated sent September 23, 2011 to all affected consignees. The letter identified the product, problem and actions to be taken. Consignees were instructed to complete requested information, return affected product and order replacement product. To return product and order replacement product, consignees were instructed to contact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. For questions call 405-917-8556.
Quantity in Commerce 15 units
Distribution Nationwide Distribution (USA) including the states of: MI, NH, OK.
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 = GCJ and Original Applicant = WORLD OF MEDICINE LEMKE GMBH
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