| Date Initiated by Firm | October 02, 2006 |
|---|
| Date Posted | February 01, 2007 |
|---|
| Recall Status1 |
Terminated 3 on February 02, 2016 |
| Recall Number | Z-0397-2007 |
|---|
| Recall Event ID |
37143 |
| 510(K)Number | K060948 |
|---|
| Product Classification |
dermatological - Product Code GEI
|
| Product | Portrait PSR3 System, an electro-surgical device used in dermatological applications |
|---|
| Code Information |
Software versions prior to Version V2.0A |
| FEI Number |
3004948955
|
Recalling Firm/
Manufacturer |
Rhytec Inc.
130 Turner St
Building 2
Waltham
MA
02453-8901
|
Manufacturer Reason
for Recall | Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Rhytec notified users by letter dated 10/2/06 of the software upgrade. A service representative will perform the update. |
|---|
| Quantity in Commerce | 234 units |
|---|
| Distribution | Canada, Australia, Brazil, Korea |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = GEI
|
|---|
