Recall Z-0427-2014— Cutera, Inc.

Name: FDA recall Z-0427-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-16

Class II · Terminated

Class II FDA medical device recall by Cutera, Inc., initiated 2013-10-16, terminated 2013-12-09. It names one FDA 510(k) clearance: K122389. 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.. Reason: 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..

Recalling firm: Cutera, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-16
Terminated: 2013-12-09
Firm location: Brisbane, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K122389 — TRUSCULPTCutera, Inc.·cleared 2012-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.