Solta Medical recalls Thermage CPT System TG-2B due to potential improper calibration during manufacturing. This may affect safety in dermatological procedures. Contact Solta for details.
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Solta Medical is recalling its Thermage CPT System (model TG-2B) because it may have been improperly calibrated during manufacturing. This could lead to unsafe treatment outcomes during skin procedures.
The device may have been improperly tested and calibrated during manufacturing, which could lead to inconsistent treatment results or safety issues during procedures. This is a potential manufacturing defect that might not cause immediate harm but could affect treatment effectiveness.
Users of the Thermage CPT System (model TG-2B) for skin treatments are affected. Patients undergoing dermatological procedures with this device are at risk.
Check for the model number TG-2B on the device or its packaging. The device is used for skin treatments and is sold by Solta Medical.
Reach out to Solta Medical directly for guidance on the recall and next steps.
The device may have been improperly tested and calibrated during manufacturing, which could lead to inconsistent treatment results or safety issues during procedures.
Contact Solta Medical directly for guidance on the recall and next steps.
The recall record does not mention a specific fix or remedy.
We’ve drafted a message you can send Solta Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1354-2023 — Solta Medical Solta Medical Hello, I own a Solta Medical that is covered by recall Z-1354-2023 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.
