ConMed Linvatec Surgical Video Cart 의 리콜

Recall

48195

Class 2

Z-2458-2008

2007-10-31

2008-09-21

Terminated

United States

2008-09-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70983

The recall was initiated because conmed linvatec has determined there is a possibility the wheel caster(s) may become loose which may result in the wheel caster(s) falling out of the base of the vp8500 video cart. the potential for the wheel caster or casters to fall out of the base of the cart may result in a potential tip hazard.

The recall was initiated by the firm sending the recall information packet via UPS overnight delivery to the Distribution and Sales Force in May 2008. The packet included: 1. Recall Notification and reply form for each consignee. 2. Instructions on the procedure to conduct the recall of the VP8500. 3. A list of affected consignees in their territory. The Recall Notification informed the customers of the potential for the wheel caster(s) to fall out of the base of the cart which may result in a potential tip hazard. The customers were instructed to discontinue the use of the VP8500 Video Cart immediately if the wheel caster(s) show any signs of being loose and to complete the recall reply form. Upon receipt of notification, distributors are supposed to : 1. Visit the affected accounts and provide them with a copy of the Recall Notification to inform them of the recall and the Recall Acknowledgment Reply Form which is to be mailed or faxed back to the firm. 2. Schedule the delivery and installation of refurbished carts to replace the recalled cart(s) by contacting Jill Cover, ConMed Linvatec Endoscopy Division at (888) 292-0100, ext. 8157 or e-mail jcover@livatec.com to arrange for replacement. 3. Move medical devices, etc. from the recalled cart(s) and set up the refurbished cart(s) with the required equipment at the account's location. (ProMEDICA will arrange for shipping of the recalled cart(s) back to ProMEDICA.)