Recall Z-0933-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Sound Surgical Technologies, LLC
Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.
| Date | Mar 13, 2008 (initiated Dec 28, 2007) |
| Status | Terminated |
| Reason | Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed. |
| Root cause | Device Design |
| Action | Consignees were sent an Advisory Notice on 12/28/2007. The notification describes the defect. Sound Surgical will be contacting facilities to arrange a service call to install new cables between the footswitch receiver and the VASER system. Facilities may contact the Technical Service Center at 1-888-677-8765. |
| Quantity | 127 switches |
| Distribution | Worldwide Distribution including USA states of AL, CA, CT, FL, GA, IN, KY, LA, MI, NJ, NY, OH, OK, PA, TX, and VA. Foreign Distribution to Colombia, Costa Rica and Switzerland. |
| FDA record | Open on fda.gov |