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Terminated

Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.

FDA Recall Z-0933-2008 · Posted 2008-03-13

Recalling FirmSound Surgical Technologies, LLC
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-12-28
Date Terminated2008-04-01
Product Quantity127 switches

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053510IR WIRELESS FOOT SWITCHLinemaster Switch Corp. · 2006-03-20K022051SOUNDVASER SYSTEMSound Surgical Technologies, LLC · 2002-09-11K993868THE SOUNDVASER DISSECTION SYSTEMSound Surgical Technologies, LLC · 1999-12-21K991791SOUND VASER SYSTEMSound Surgical Technologies, LLC · 1999-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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