Solta Medical recalls Thermage Face Tip 3.0 devices with specific model numbers due to complaints of sparking during RF surgical procedures, which may cause skin burns. Affected units include certain production dates and lot numbers.
Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
Solta Medical is recalling Thermage Face Tip 3.0 devices that have been reported to spark during RF surgical procedures, potentially causing skin burns. Owners should check their model numbers and production dates to see if they are affected.
The affected tips can spark during use, which may lead to skin burns. This occurs because the electrosurgical device is designed for RF procedures but has a defect that causes unintended electrical sparks.
Users of Thermage Face Tip 3.0 devices for surgical procedures are affected. Patients undergoing RF treatments with these specific model numbers are at risk of skin burns.
Check the model number on the device, which includes TTNS3.00C3-400, TTNS3.00C3-600, or TTNS3.00C3-900. Affected units were manufactured between specific dates (DOM) listed in the recall notice.
Look for the model number on the device, which should be TTNS3.00C3-400, TTNS3.00C3-600, or TTNS3.00C3-900.
Contact Solta Medical directly to confirm if your device is affected and to get instructions for next steps.
The affected model numbers are TTNS3.00C3-400, TTNS3.00C3-600, and TTNS3.00C3-900.
Check the model number on the device and compare it to the affected models listed in the recall notice. Also, verify the production date (DOM) as specified in the recall.
Contact Solta Medical directly to confirm if your device is affected and to get instructions for next steps.
We’ve drafted a message you can send Solta Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1681-2020 — Solta Medical Solta Medical Hello, I own a Solta Medical that is covered by recall Z-1681-2020 from Solta Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.