***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.
This recall has been terminated (originally issued April 5, 2011).
- Recall Initiated
- September 17, 2010
- Posted
- April 5, 2011
- Terminated
- May 17, 2011
- Recall Number
- Z-1893-2011
- Quantity
- 373
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- Australia, Canada, Morocco, Saudi Arabia, Taiwan, Province of China, and throughout the U.S.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.