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U.S. Department of Health and Human Services

Class 2 Device Recall Portrait

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 Class 2 Recall
Portrait
see related information
Date Posted February 01, 2007
Recall Status1 Open
Recall Number Z-0397-2007
Recall Event ID 37143
Premarket Notification
510(K) Number
K060948 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - 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, Massachusetts 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
DESIGN: Labeling Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = RHYTEC INCORPORATED
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