Cutera truSculpt Infrared System Recalled for Thermal Burn Risk
Cutera is recalling 451 truSculpt infrared systems because the device caused partial thickness thermal burns to the skin in two patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported injuries (partial thickness thermal burns), which meets the criteria for a Severe severity score.
Plain-English summary
Cutera, Inc. is recalling 451 units of the truSculpt infrared System, a medical device intended to provide topical heating for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The device is also intended to provide a temporary reduction in the appearance of cellulite.
The recall was initiated after Cutera received reports of two adverse events associated with the edge of the electrode. In both instances, the electrode was pressed against neck skin over the thyroid cartilage. Due to the absence of adequate underlying conductive tissue, increased skin heating occurred, resulting in linear welts and blisters consistent with partial thickness thermal burns.
The affected units were distributed nationwide in the United States and internationally to Canada. Consumers and healthcare providers should stop using the device and contact Cutera, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- 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.…
- Manufacturer
- Cutera, Inc.
- Hazard
- Affected units
- 451
Distribution
Distributed nationwide across the United States.
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