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U.S. Department of Health and Human Services

Class 2 Device Recall Linemaster Wireless Footswitch

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 Class 2 Recall
Linemaster Wireless Footswitch
see related information
Date Posted January 25, 2011
Recall Status1 Terminated on February 08, 2011
Recall Number Z-0939-2011
Recall Event ID 57630
Premarket Notification
510(K) Numbers
K022051  K053510  K991791  K993868 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, Louisville, CO 80027
Code Information Serial numbers VNT10-0102 thru VNT10-0128.
Recalling Firm/
Manufacturer
Sound Surgical Technologies, LLC
357 Mccaslin Blvd Ste 100
Louisville, Colorado 80027-2951
Manufacturer Reason
for Recall
Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 .
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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