# FDA recall Z-1354-2023

> **Solta Medical Inc** · Class II · device recall initiated 2023-02-16.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-1354-2023
- **Recalling firm:** Solta Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-16
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1354-2023

## Citation

> AI Analytics. FDA recall Z-1354-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1354-2023. Source: US FDA. Licensed CC0.

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