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U.S. Department of Health and Human Services

Class 2 Device Recall Wireless footswitch.

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 Class 2 Recall
Wireless footswitch.
see related information
Date Posted March 13, 2008
Recall Status1 Terminated on April 01, 2008
Recall Number Z-0933-2008
Recall Event ID 46293
Premarket Notification
510(K) Numbers
K022051  K053510  K991791  K993868 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.
Code Information Model SP-9970214-005112010 and SP-9970214-005112232. All units.
Recalling Firm/
Manufacturer
Sound Surgical Technologies, LLC
357 Mccaslin Blvd Ste 100
Louisville, Colorado 80027-2951
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = LINEMASTER SWITCH CORP.
510(K)s with Product Code = GEI and Original Applicant = SOUND SURGICAL TECHNOLOGIES LLC.
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