Portrait PSR3 System, an electro-surgical device used in dermatological applications
FDA device recall Z-0397-2007 · posted 2007-02-01 · Terminated
Recall details
- Recalling firm
- Rhytec Inc.
- Reason for recall
- Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz
- Action taken
- Rhytec notified users by letter dated 10/2/06 of the software upgrade. A service representative will perform the update.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 234 units
- Distribution
- Canada, Australia, Brazil, Korea
- Date initiated
- 2006-10-02
- Date posted
- 2007-02-01
- Date terminated
- 2016-02-02
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORTRAIT PSR3 (K060948) | Rhytec Incorporated | 2006-09-05 |