thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. D
FDA device recall Z-1354-2023 · posted 2023-04-07 · Open, Classified
Recall details
- Recalling firm
- Solta Medical Inc
- Reason for recall
- A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
- Action taken
- On 02/16/2023, the firm contacted customer via telephone e and then coordinate shipping out a loaner device as well as getting the unit (s/n: 001933) back for retest and possible recalibration. Documentation for the recall will be mailed with the loaner system to the customer. If you have any questions, contact Senior Director, Global Product Support at 425-420-2352 or email: Jody.Johnson@solta.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 1 unit
- Distribution
- U.S. Distribution to state of: MD
- Date initiated
- 2023-02-16
- Date posted
- 2023-04-07
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Thermage CPT System and Accessories (K173759) | Solta Medical | 2018-01-08 |