Recall Z-2458-2008 ยท KQM Camera, Surgical And Accessories
Conmed Linvatec Endoscopy Division
ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500
| Date | Sep 21, 2008 (initiated Oct 31, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 Car |
| Quantity | 45 Units Worlwide (42 in US) |
| Distribution | Worldwide Distribution including states of: AK, AZ, CA, FL, GA, IL, IN, KS, MD, NC, NY, OH, and PA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.