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

FDA Device Recall #Z-0427-2014 — Class II — October 16, 2013

Recall Summary

Recall Number Z-0427-2014
Classification Class II — Moderate risk
Date Initiated October 16, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cutera, Inc.
Location Brisbane, CA
Product Type Devices
Quantity 451

Product Description

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.

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.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada

Lot / 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

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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