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Terminated

PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma

FDA Recall Z-2123-2014 · Posted 2014-07-28

Recalling FirmRa Medical Systems Inc
Recall StatusTerminated
Product CodeGEX
Date Initiated2014-06-30
Date Terminated2014-09-09
Product Quantity435 units

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.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062963PHAROS EXCIMER LASER SYSTEM, MODEL EX-308Ra Medical Systems,Inc · 2007-04-03

Official Source

View FDA Recall →

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

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