Z-0556-03

ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only

Name: Z-0556-03 ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
Creator: Thermage
Published: 2002-12-09
License: https://open.fda.gov/license/

Solta Medical, Inc. / initiated 2002-12-09 / Terminated

FDA source

Thermage began a recall of ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only on 2002-12-09. The reason FDA records is "Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0556-03
Status: Terminated
Initiated: 2002-12-09
Posted: 2003-02-13
Terminated: 2003-04-30
Recalling firm: Solta Medical, Inc.
Product: ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
FDA root cause: Other
Action: The recall notification was faxed to all 54 consignees on 12/8/02. A follow-up hard copy of the recall notification was sent via FedEx on 12/9/02.
Quantity in commerce: 1,326 units
Distribution: The product was distributed nationwide. A total of 54 consignees received the product. The recall was appropriately extended to the user level; i.e., the wholesalers/distributors, hospitals and medical supply distributors, and physicians who received the recalled product. There is no known U. S. Government or Canadian distribution.
Product codes and lots: M00023, M00024, M00029, M00031, M00033R, M00034, M00035,

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)