Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactur
FDA device recall Z-0427-2014 · posted 2013-12-09 · Terminated
Recall details
- Recalling firm
- Cutera, Inc.
- 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.
- Action taken
- 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. Customers with questions were instructed to call 415-657-5500 or 415-657-5568.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- OPT
- Quantity affected
- 451
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada
- Date initiated
- 2013-10-16
- Date posted
- 2013-12-09
- Date terminated
- 2013-12-09
- Location
- Brisbane, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUSCULPT (K122389) | Cutera, Inc. | 2012-11-02 |