Events

Recall of Device Recall Portrait

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rhytec Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37143
  • Event Risk Class
    Class 2
  • Event Number
    Z-0397-2007
  • Event Initiated Date
    2006-10-02
  • Event Date Posted
    2007-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49975
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    dermatological - Product Code GEI
  • Reason
    Inadequate directions for use: software upgrade to set maximum energy level at 2.5 hz.
  • Action
    Rhytec notified users by letter dated 10/2/06 of the software upgrade. A service representative will perform the update.

Device

Device Recall Portrait
  • Model / Serial
    Software versions prior to Version V2.0A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Australia, Brazil, Korea
  • Product Description
    Portrait¿ PSR3 System, an electro-surgical device used in dermatological applications
  • Manufacturer
    Rhytec Inc.

Manufacturer

Rhytec Inc.
  • Manufacturer Address
    Rhytec Inc., 130 Turner St, Building 2, Waltham MA 02453-8901
  • Source
    USFDA