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U.S. Department of Health and Human Services

Class 2 Device Recall HD Still Capture

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  Class 2 Device Recall HD Still Capture see related information
Date Initiated by Firm March 18, 2013
Date Posted May 20, 2013
Recall Status1 Terminated 3 on November 06, 2013
Recall Number Z-1340-2013
Recall Event ID 64647
Product Classification Camera, surgical and accessories - Product Code KQM
Product Ref: VP1600 HD Still Capture System ConMed Linvatec .


Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
Code Information VP1600
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
727-399-5205
Manufacturer Reason
for Recall		 The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action The firm, ConMed, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated 3/8/2013 to its customers after initial phone notifications. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce 267 units
Distribution Worldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia.
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.
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