Recall Z-0397-2007 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Rhytec Inc.
Portrait PSR3 System, an electro-surgical device used in dermatological applications
| Date | Feb 1, 2007 (initiated Oct 2, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060948 | PORTRAIT PSR3 Rhytec Incorporated, Sep 5, 2006 |