Recall Z-0939-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Sound Surgical Technologies, LLC
Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027
| Date | Jan 25, 2011 (initiated Dec 21, 2010) |
| Status | Terminated |
| Reason | Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed. |
| Root cause | Process control |
| Action | Customers were notified by e-mail with an Advisory Notice on 12/21/2010. The Notice identified the affected product and described the issue. The Notice also explained what the potential hazard involved along with a mechanism to eliminate the potential hazard. Sound Surgical would arrange a service call to implement the correction at the firm's expense. If customers experience this potential failure, they are to contact Sound Surgical Technologies at 1-888-677-8765 or 1-888-471-4777. |
| Quantity | 27 units |
| Distribution | Nationwide Distribution -- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX . |
| FDA record | Open on fda.gov |