| Class 2 Device Recall Wireless footswitch. | |
Date Initiated by Firm | December 28, 2007 |
Date Posted | March 13, 2008 |
Recall Status1 |
Terminated 3 on April 01, 2008 |
Recall Number | Z-0933-2008 |
Recall Event ID |
46293 |
510(K)Number | K022051 K053510 K991791 K993868 |
Product Classification |
Electrosurgical cutting & coagulation & accessories - Product Code GEI
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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 CO 80027-2951
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For Additional Information Contact | 303-926-8608 Ext. 1007 |
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 | 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 |
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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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