FDAClass IIApril 19, 2023

thermage THERMAGE CPT SYSTEM recall

thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general…

Why was thermage THERMAGE CPT SYSTEM recalled?

A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933

Product
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general…
Recalling firm
Solta Medical Inc
Quantity
1 unit
Distribution
U.S. Distribution to state of: MD
Recall date
April 19, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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