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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 Posted December 09, 2013
Recall Status1 Terminated 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
415-657-5500
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 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.
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