Z-0939-2011

Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South...

Name: Z-0939-2011 Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South...
Creator: Sound Surgical Technologies, LLC
Published: 2010-12-21
License: https://open.fda.gov/license/

Solta Medical, Inc. / initiated 2010-12-21 / Terminated / root cause: manufacturing process

FDA source

Sound Surgical Technologies, LLC began a recall of Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027 on 2010-12-21. The reason FDA records is "Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0939-2011
Status: Terminated
Initiated: 2010-12-21
Posted: 2011-01-25
Terminated: 2011-02-08
Recalling firm: Solta Medical, Inc.
Product: Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
Root cause tag: manufacturing process
FDA 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 in commerce: 27 units
Distribution: Nationwide Distribution -- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX .
Product codes and lots: Serial numbers VNT10-0102 thru VNT10-0128.

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)