PlainRecordsFDA · Medical device recall
Portrait PSR3 System…
- Date posted by the FDA
- Feb. 1, 2007
- Status
- Terminated
- Filed by
- Rhytec Inc.
- Product
- Portrait PSR3 System, an electro-surgical device used in dermatological applications
- Reason
- Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz
- Distribution pattern
- Canada, Australia, Brazil, Korea
- Quantity
- 234 units
- Codes and lots
- Software versions prior to Version V2.0A
- Recall started
- Oct. 2, 2006
- Device type
- Electrosurgical, Cutting & Coagulation & Accessories
- Root cause (FDA)
- Other
- What the company told customers
- Rhytec notified users by letter dated 10/2/06 of the software upgrade. A service representative will perform the update.
- Recall number
- Z-0397-2007
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-0397-2007. The agency record governs; check it and the company before acting.