Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0427-2014 — 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

U.S. FDA — Device Enforcement · United States · 2013-10-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0427-2014
Date of alert: 2013-10-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cutera, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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