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U.S. Department of Health and Human Services

Class 2 Device Recall PHAROS Excimer Laser

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  Class 2 Device Recall PHAROS Excimer Laser see related information
Date Initiated by Firm June 30, 2014
Date Posted July 28, 2014
Recall Status1 Terminated 3 on September 09, 2014
Recall Number Z-2123-2014
Recall Event ID 68706
510(K)Number K062963  
Product Classification Powered laser surgical instrument - Product Code GEX
Product PHAROS Excimer Laser, Model No. EX-308

UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
Code Information Serial Numbers:  40 41 99 112 114 119 124 234 237 250 251 271 272 274 276 283 299 302 306 314 315 316 319 321 323 324 325 326 329 333 337 350 351 352 356 357 358 359 360 382 383 394 396 397 398 400 402 404 405 407 409 411 414 417 418 419 420 421 423 424 428 430 431 441 450 455 457 459 460 462 463 464 465 467 471 475 476 480 482 483 484 486 488 490 491 494 495 496 497 500 505 507 509 512 516 518 519 525 526 527 528 529 531 532 533 534 535 537 538 539 541 543 546 550 552 553 554 555 556 557 559 560 561 562 563 565 566 567 570 571 572 573 574 576 579 580 582 583 585 586 588 589 591 592 593 594 595 597 598 599 600 601 602 603 604 605 606 609 610 614 615 617 622 623 624 628 629 631 632 633 635 636 637 638 639 644 645 646 647 648 649 654 655 656 657 659 661 662 663 664 665 667 668 669 672 673 674 678 682 683 684 685 686 687 688 689 690 692 694 695 697 698 699 700 702 703 705 706 707 708 709 712 713 714 715 716 717 718 719 720 721 722 901 902 903 904 905 908 909 911 912 914 915 916 917 918 921 922 923 925 926 927 928 929 930 931 932 933 935 936 938 939 940 941 942 943 944 948 949 950 951 952 954 955 956 957 958 959 960 961 962 963 964 967 968 969 970 971 972 973 974 975 976 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 999 1000 1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1014 1015 1016 1017 1018 1021 1022 1023 1024 1025 1027 1028 1029 1030 1031 1032 1034 1035 1036 1037 1039 1040 1041 305 307 327 331 386 415 425 437 443 444 445 446 447 448 540 577 578 618 619 620 621 353 454 312 322 328 330 335 346 348 349 370 381 385 387 410 510 511 515 524 558 575 608 
Recalling Firm/
Manufacturer		 Ra Medical Systems Inc
1930 Kellogg Ave
Carlsbad CA 92008-6581
For Additional Information Contact
760-804-1648
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 435 units
Distribution Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = RA MEDICAL SYSTEMS, INC.
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