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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 Device Recall Linemaster Wireless Footswitch see related information
Date Initiated by Firm December 21, 2010
Date Posted January 25, 2011
Recall Status1 Terminated 3 on February 08, 2011
Recall Number Z-0939-2011
Recall Event ID 57630
510(K)Number K053510  K991791  K993868  K022051  
Product Classification Electrosurgical Cutting and Coagulation Device and 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 CO 80027-2951
For Additional Information Contact
720-240-2970
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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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