Recall Z-0556-03 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Thermage
ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
| Date | Feb 13, 2003 (initiated Dec 9, 2002) |
| Status | Terminated |
| Reason | Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury. |
| Root cause | Other |
| Action | The recall notification was faxed to all 54 consignees on 12/8/02. A follow-up hard copy of the recall notification was sent via FedEx on 12/9/02. |
| Quantity | 1,326 units |
| Distribution | The product was distributed nationwide. A total of 54 consignees received the product. The recall was appropriately extended to the user level; i.e., the wholesalers/distributors, hospitals and medical supply distributors, and physicians who received the recalled product. There is no known U. S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.