Recall Z-2123-2014 ยท GEX Powered Laser Surgical Instrument
Ra Medical Systems Inc
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
| Date | Jul 28, 2014 (initiated Jun 30, 2014) |
| Status | Terminated |
| Reason | RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed. |
| Root cause | Error in labeling |
| Action | Ra Medical Systems sent a customer letter dated June 30, 2014, to who purchased the PHAROS EX-308 Excimer Laser Phototherapy System Hand Piece. The letter informed the customers of the problems identified and the actions to be taken. Customers were also provided with the Instructions for Use (IFU) for the PHAROS EX-308 Excimer Laser Phototherapy System Hand Piece and a replacement iris indication label for the handpiece. |
| Quantity | 435 units |
| Distribution | Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062963 | PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 Ra Medical Systems,Inc, Apr 3, 2007 |