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U.S. Department of Health and Human Services

Class 2 Device Recall Articulating Arm, Secondary Flat Panel

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  Class 2 Device Recall Articulating Arm, Secondary Flat Panel see related information
Date Initiated by Firm September 17, 2010
Date Posted April 05, 2011
Recall Status1 Terminated 3 on May 17, 2011
Recall Number Z-1893-2011
Recall Event ID 58009
Product Classification Surgical Camera and Accessories - Product Code KQM
Product ***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA***

Catalog No Product
VPN6528 Articulating Arm, Secondary Flat Panel.
690-0024-00 Arm, Wall Mount, Flat Screen, GCX

For mounting and positioning of flat screen monitors.
Code Information Serial Numbers: 0409 080422004 081117004 1056 1268 1314 1505 1539 1588 1661 178 1828 1896 2082 2289 2424 2543 2651 2752 2993 3343 3423 3424 3486 3507 3531 3588 3600 3611 366 3671 3701 3831 424 4269 461 6054 615 6238 652 735 787 847 887 955, and  989. 
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
727-392-6464
Manufacturer Reason
for Recall		 If the VHM Arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement.
FDA Determined
Cause 2		 Device Design
Action An Urgent Service Bulletin Notification was mailed to each ConMed Linvatec customer who received the affected product. The letter identified the affected product and stated the reason for notification. The letter asks customers to review the GCX Corporation Service Bulletins and updated Installation/User Manual. ConMed Linvatec recommends that customers periodically check the VHM Arm to see that it is functioning properly. In addition "Sudden Movement" stickers, provided by GCX, were also included to all consignees as part of the mailing. If customers in the US have questions or need technical support, they can contact ConMed Linvatec Endoscopy Customer Service at 888-292-0100 or e-mail Customerserv1@linvatec.com.
Quantity in Commerce 373
Distribution Worldwide Distribution -- Australia, Canada, Morocco, Saudi Arabia, Taiwan, Province of China, and throughout the U.S.
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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