Thermage TG-2BRecalls & reported problems
Solta Medical · THERMACOOL, CPT · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Feb 16, 2023Open, Classified
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Z-1354-2023 · Root cause: Process control · FDA record ↗
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- THERMAGE FLX TT4.00F6-600Solta Medical · Massager, Therapeutic, Electric8 reports
- THERMAGE FLX TT16.00F6-500Solta Medical · Massager, Therapeutic, Electric6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.