Reported Dec 18, 2013 · Terminated
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is…
Cutera, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cutera, Inc. · 3240 Bayshore Blvd · Brisbane, CA · 94005-1021
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
84 of 84 codes
TS10140TS10052TS10107TS10161TS10086TS10136TS10083TS10045TS10032TS10075TS10100TS10070TS10129TS10049TS10040TS10055TS10160TS10046TS10117TS10137TS10141TS10080TS10097TS10037TS10131TS10138TS10119TS10088TS10074TS10114TS10145TS10066TS10106TS10155TS10056TS10094TS10139TS10022TS10128TS10112TS10068TS10124TS10078TS10134TS10079TS10002TS10109TS10156TS10135TS10110TS10008TS10115TS10093TS10146TS10050TS10017TS10054TS10029TS10104TS10048
- Serial Numbers
- Amount recalled
- 451
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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