Z-0933-2008

Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound...

Name: Z-0933-2008 Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound...
Creator: Sound Surgical Technologies, LLC
Published: 2007-12-28
License: https://open.fda.gov/license/

Solta Medical, Inc. / initiated 2007-12-28 / Terminated / root cause: design

FDA source

Sound Surgical Technologies, LLC began a recall of Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027 on 2007-12-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0933-2008
Status: Terminated
Initiated: 2007-12-28
Posted: 2008-03-13
Terminated: 2008-04-01
Recalling firm: Solta Medical, Inc.
Product: Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: Model SP-9970214-005112010 and SP-9970214-005112232. All units.

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)