Recall Z-0427-2014 ยท OPT Infrared Hematoma Detector
Cutera, Inc.
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 tissu
| Date | Dec 9, 2013 (initiated Oct 16, 2013) |
| Status | Terminated |
| 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. |
| 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. C |
| Quantity | 451 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122389 | TRUSCULPT Cutera, Inc., Nov 2, 2012 |