PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and
FDA device recall Z-2123-2014 · posted 2014-07-28 · Terminated
Recall details
- Recalling firm
- Ra Medical Systems Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 435 units
- Distribution
- Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia.
- Date initiated
- 2014-06-30
- Date posted
- 2014-07-28
- Date terminated
- 2014-09-09
- Location
- Carlsbad, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 (K062963) | Ra Medical Systems,Inc | 2007-04-03 |