FDA Medical Device Recalls (openFDA)
Thermage: ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
- Recall number
- Z-0556-03
- Recalling firm
- Thermage
- Product
- ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
- Status
- Terminated
- Initiated
- 2002-12-09
- Posted
- 2003-02-13
- Terminated
- 2003-04-30
- Reason
- Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
- 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
- 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.
- Lot, serial or model codes
- M00023, M00024, M00029, M00031, M00033R, M00034, M00035,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3003079710
- Firm city
- Hayward
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28