FDA Medical Device Recalls (openFDA)
Rhytec Inc.: Portrait PSR3 System, an electro-surgical device used in dermatological applications
- Recall number
- Z-0397-2007
- Recalling firm
- Rhytec Inc.
- Product
- Portrait PSR3 System, an electro-surgical device used in dermatological applications
- Status
- Terminated
- Initiated
- 2006-10-02
- Posted
- 2007-02-01
- Terminated
- 2016-02-02
- Reason
- Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz
- Root cause
- Other
- Action
- Rhytec notified users by letter dated 10/2/06 of the software upgrade. A service representative will perform the update.
- Quantity
- 234 units
- Distribution
- Canada, Australia, Brazil, Korea
- Lot, serial or model codes
- Software versions prior to Version V2.0A
- 510(k) numbers
- ["K060948"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004948955
- Firm city
- Waltham
- Firm state
- MA
- 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