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U.S. Department of Health and Human Services

Class 2 Device Recall ENDOSCOPIC Camera

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 Class 2 Recall
ENDOSCOPIC Camera
see related information
Date Posted October 21, 2011
Recall Status1 Open
Recall Number Z-0082-2012
Recall Event ID 60054
Premarket Notification
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, Massachusetts 01810-1031
Manufacturer Reason
for Recall
HD1200 camera heads may cause image issues
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 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 = GCJ and Original Applicant = WORLD OF MEDICINE LEMKE GMBH
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