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U.S. Department of Health and Human Services

Class 2 Device Recall truSculpt

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  Class 2 Device Recall truSculpt see related information
Date Initiated by Firm October 16, 2013
Date Posted December 09, 2013
Recall Status1 Terminated 3 on December 09, 2013
Recall Number Z-0427-2014
Recall Event ID 66674
510(K)Number K122389  
Product Classification Massager, vacuum, radio frequency induced heat - Product Code OPT
Product Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA

The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
Code Information Serial Numbers: TS10140 TS10052 TS10107 TS10161 TS10086 TS10136 TS10083 TS10045 TS10032 TS10075 TS10100 TS10070 TS10129 TS10049 TS10040 TS10055 TS10160 TS10046 TS10117 TS10137 TS10141 TS10080 TS10097 TS10037 TS10131 TS10138 TS10119 TS10088 TS10074 TS10114 TS10145 TS10066 TS10106 TS10155 TS10056 TS10094 TS10139 TS10022 TS10128 TS10112 TS10068 TS10124 TS10078 TS10134 TS10079 TS10002 TS10109 TS10156 TS10135 TS10110 TS10008 TS10115 TS10093 TS10146 TS10050 TS10017 TS10054 TS10029 TS10104 TS10048 TS10090 TS10062 TS10024 TS10158 TS10071 TS10035 TS10059 TS10153 TS10025 TS10087 TS10130 TS10133 TS10101 TS10103 TS10125 TS10018 TS10089 TS10023 TS10147 TS10033 TS10015 TS10014 TS10039 TS10085 
Recalling Firm/
Manufacturer		 Cutera, Inc.
3240 Bayshore Blvd
Brisbane CA 94005-1021
For Additional Information Contact Bradley Renton
415-657-5500
Manufacturer Reason
for Recall		 Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.
FDA Determined
Cause 2		 Employee error
Action Cutera sent an IMPORTANT SAFETY INFORMATION letter dated October 16, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. It is important that you share this correspondence and the updated Operator Manual andvtreatment guidelines with all staff at your office that use the truSculpt, so they are aware of this new safety information. Please immediately remove and dispose of the current truSculpt Operator Manual and clinical guidelines and replace them with the new and revised truSculpt Operator Manual and clinical guidelines. Customers with questions were instructed to call 415-657-5500 or 415-657-5568.
Quantity in Commerce 451
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada
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 = OPT and Original Applicant = CUTERA, INC.
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