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Terminated

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

FDA Recall Z-0397-2007 · Posted 2007-02-01

Recalling FirmRhytec Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-10-02
Date Terminated2016-02-02
Product Quantity234 units

Reason for Recall

Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz

Firm Action

Rhytec notified users by letter dated 10/2/06 of the software upgrade. A service representative will perform the update.

Root Cause

Other

Distribution Pattern

Canada, Australia, Brazil, Korea

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060948PORTRAIT PSR3Rhytec Incorporated · 2006-09-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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