FDA Medical Device Recalls (openFDA)
Solafeet, Inc.: Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner.
- Recall number
- Z-0608-2010
- Recalling firm
- Solafeet, Inc.
- Product
- Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner.
- Status
- Terminated
- Initiated
- 2009-09-08
- Posted
- 2010-02-16
- Terminated
- 2012-08-21
- Reason
- Product failed to have a label that contained a recommended exposure schedule; the operator's manual provided inadequate instructions for use; and label implication may result in overexposure.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Solafeet sent letters to customers informing them that the labeling and instructions included with the product were not in accordance with the FDA requirements. Attached with the letter was a replacement label and a replacement set of instructions. Customers are to attach the new label on top of the old label and use the new instructions, noting the change in exposure limits. Questions should be directed to 941-359-2608 or info@solafeet.com.
- Quantity
- 72 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Any codes associated with Model ST-400.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REG
- Firm FEI
- 3007708365
- Firm city
- Sarasota
- Firm state
- FL
- 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