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 |
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 and Original Applicant = RHYTEC INCORPORATED
|