| Class 2 Device Recall Linemaster Wireless Footswitch | |
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 | K022051 K053510 K991791 K993868 |
Product Classification |
Electrosurgical Cutting and Coagulation Device and Accessories - Product Code GEI
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI 510(K)s with Product Code = GEI
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