Z-0397-2007

Portrait PSR3 System, an electro-surgical device used in dermatological applications

Name: Z-0397-2007 Portrait PSR3 System, an electro-surgical device used in dermatological applications
Creator: Rhytec Inc.
Published: 2006-10-02
License: https://open.fda.gov/license/

Rhytec Inc. / initiated 2006-10-02 / Terminated / root cause: software

FDA source

Rhytec Inc. began a recall of Portrait PSR3 System, an electro-surgical device used in dermatological applications on 2006-10-02. The reason FDA records is "Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0397-2007
Status: Terminated
Initiated: 2006-10-02
Posted: 2007-02-01
Terminated: 2016-02-02
Recalling firm: Rhytec Inc.
Product: Portrait PSR3 System, an electro-surgical device used in dermatological applications
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz
Root cause tag: software
FDA 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 in commerce: 234 units
Distribution: Canada, Australia, Brazil, Korea
Product codes and lots: Software versions prior to Version V2.0A

Product code GEI

K060948Class IIPortrait Psr3Rhytec Incorporated / cleared 2006-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)