Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027
FDA Recall Z-0939-2011 · Posted 2011-01-25
Recalling FirmSound Surgical Technologies, LLC
Recall StatusTerminated
Product CodeGEI
Date Initiated2010-12-21
Date Terminated2011-02-08
Product Quantity27 units
Reason for Recall
Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution -- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX .
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.