PHAROS Excimer Laser
Medical device recall Z-2123-2014. Published in FDA’s Enforcement Report on Aug 6, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 6, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 435 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
435 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,614 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 30, 2014.
- FDA classified it on Jul 28, 2014.
- FDA’s Enforcement Report published it on Aug 6, 2014.
- FDA terminated it on Sep 9, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ra Medical Systems Inc, of Carlsbad, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.