Z-0427-2014Class II

Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is...

Name: Z-0427-2014 Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is...
Creator: Cutera, Inc.
Published: 2013-10-16
License: https://open.fda.gov/license/

Cutera Inc / initiated 2013-10-16 / Terminated / root cause: manufacturing process

FDA source

Cutera, Inc. began a recall of Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc... on 2013-10-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0427-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-16
Posted: 2013-12-09
Terminated: 2013-12-09
Recalling firm: Cutera Inc
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.
Product code: OPT Infrared Hematoma Detector
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0427-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0427-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-09

Product code OPT

K122389Class IITrusculptCutera, Inc. / cleared 2012-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)