thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.
Summary
The FDA issued a Class II for thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENE by Solta Medical Inc. Reason: A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station..
Details
Source
Device Recall
External ID
Z-1354-2023
Action Date
2023-04-19
Status
Ongoing
Category
device
Product Description
thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips.
Lot/Code Info: Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933
Quantity Affected: 1 unit
Reason for Recall
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Distribution
U.S. Distribution to state of: MD
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-16
Company
Bothell, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 135 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Solta Medical Inc has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Solta Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Solta Medical Inc have FDA actions?
Solta Medical Inc has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1354-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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