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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Event Detail

Event ID 63972
Product Type Devices
Status Ongoing
Recalling Firm AMS Innovative Center - San Jose
City San Jose
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-11
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
GreenLight HPS (High Performance System) GreenLight XPS ( Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center - Silicon Valley, 3070 Orchard Drive, San Jose, CA 95134. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasis. The entire laser unit and controls are contained in a single console that is connected to external electricity and are required to meet IEC 60601. HPS Part numbers: 0010-0070 to 0010-0077; XPS Part numbers: 0010-0210 Serial numbers: HPS2095R1 HPS3079C2 HPS3080C1 HPS3089C1 HPS3091C1 HPS3096C1 HPS3099C1 HPS3100C1 HPS3101C1 HPS3102C1 HPS3103 HPS3104C1 HPS3105C1 HPS3107 HPS3108C1 HPS3109C1 HPS3110C2 HPS3112 HPS3113 HPS3114 HPS3115 HPS3116 HPS3117 HPS3118 HPS3119 HPS3120 HPS3121 HPS3122 HPS3123 HPS3124 HPS3125 HPS3126 HPS3127 HPS3128 HPS3129 HPS3130 HPS3131 HPS3132 HPS3134 HPS3136 HPS3137 HPS3139 HPS3142 HPS3143 HPS3144 HPS3145 XPS50084 XPS50241 XPS50301 XPS50302 XPS50312 XPS50313 XPS50314 XPS50315 XPS50316 XPS50317 XPS50318 XPS50319 XPS50320 XPS50321 XPS50322 XPS50323 XPS50324 XPS50325 XPS50326 XPS50327 XPS50328 XPS50329 XPS50330 XPS50331 XPS50332 XPS50333 XPS50334 XPS50335 XPS50336 XPS50337 XPS50338 XPS50339 XPS50340 XPS50341 XPS50342 XPS50343 XPS50344 XPS50345 XPS50346 XPS50347 XPS50348 XPS50349 XPS50350 XPS50351 XPS50352 XPS50353 XPS50354 XPS50355 XPS50356C1 XPS50357 XPS50358 XPS50359 XPS50360 XPS50361 XPS50362 XPS50363 XPS50364 XPS50367 XPS50368 XPS50369 XPS50371 XPS50372C1 XPS50373 XPS50374 XPS50375 XPS50376 XPS50377 XPS50378 XPS50379 XPS50380 XPS50381 XPS50382 XPS50383 XPS50384 XPS50385 XPS50386 XPS50388 XPS50389 XPS50390 XPS50391 XPS50392 XPS50393 XPS50394 XPS50395 XPS50396 XPS50397 XPS50398 XPS50399 XPS50400 XPS50401 XPS50402 XPS50403 XPS50404 XPS50405 XPS50406 XPS50407 XPS50408 XPS50409 XPS50410 XPS50412 XPS50413 XPS50414 XPS50415 XPS50416 XPS50417 XPS50418 XPS50419 XPS50420 XPS50421 XPS50422 XPS50423 XPS50424 XPS50426C1 XPS50427 XPS50428 XPS50430 XPS50431 XPS50432 XPS50433 XPS50434 XPS50435C1 XPS50436 XPS50437C1 XPS50438 XPS50439 XPS50440 XPS50441 XPS50442 XPS50443 XPS50444 XPS50446 XPS50447 XPS50448 XPS50449 XPS50450 XPS50451 XPS50452 XPS50453 XPS50454 XPS50455 XPS50456 XPS50457 XPS50458 XPS50459 XPS50460 XPS50461 XPS50462 XPS50463 XPS50464 XPS50465 XPS50466 XPS50467 XPS50468 XPS50469 XPS50470 XPS50471 XPS50472 XPS50473 XPS50474 XPS50475 XPS50476 XPS50477C1 XPS50478 XPS50479 XPS50480 XPS50481 XPS50482 XPS50483 XPS50484 XPS50485 XPS50486 XPS50487 XPS50488 XPS50489 XPS50490 XPS50491 XPS50492 XPS50493 XPS50494C1 XPS50495 XPS50496 XPS50497 XPS50498 XPS50499 XPS50500 XPS50501 XPS50502 XPS50503 XPS50504 XPS50505 XPS50506 XPS50507 XPS50508 XPS50509 XPS50510 XPS50512 XPS50513 XPS50514 XPS50516 XPS50517 XPS50518 XPS50519 XPS50520 XPS50521 XPS50522 XPS50523 XPS50525 XPS50526 XPS50527 XPS50528 XPS50529 XPS50531 XPS50532 XPS50534 XPS50535 XPS50536 XPS50537 XPS50538 XPS50539 XPS50540 XPS50541 XPS50542 XPS50543 XPS50544 XPS50545 XPS50546 XPS50547 XPS50548 XPS50549 XPS50550 XPS50551 XPS50552 XPS50553 XPS50554 XPS50555 XPS50556 XPS50557 XPS50558 XPS50559 XPS50560 XPS50561 XPS50562 XPS50563 XPS50564 XPS50565 XPS50566 XPS50567 XPS50568 XPS50570 XPS50572 XPS50573 XPS50574 XPS50575 XPS50576 XPS50577 XPS50578 XPS50579 XPS50580 XPS50581 XPS50582 XPS50583 XPS50584 XPS50585 XPS50586 XPS50587 XPS50588 XPS50589 XPS50590 XPS50591 XPS50592 XPS50593 XPS50594 XPS50595 XPS50596 XPS50597 XPS50598 XPS50599 XPS50600 XPS50601 XPS50602 XPS50603 XPS50604 XPS50606 XPS50607 XPS50608 XPS50610 XPS50611 XPS50612 XPS50613 XPS50614 XPS50615 XPS50616 XPS50617 XPS50618 XPS50619 XPS50620 XPS50621 XPS50622 XPS50623 XPS50624 XPS50625 XPS50627 XPS50628 XPS50629 XPS50630 XPS50631 XPS50632 XPS50634 XPS50635 XPS50636 XPS50637 XPS50638 XPS50640 XPS50641 XPS50642 XPS50643 XPS50644 XPS50645 XPS50646 XPS50647 XPS50648 XPS50649 XPS50650 XPS50651 XPS50652 XPS50653 XPS50654 XPS50655 XPS50656 XPS50657 XPS50658 XPS50659 XPS50660 XPS50661 XPS50662 XPS50663 XPS50671 XPS50674 XPS50675 XPS50676 XPS50680 XPS50681 XPS50684. Class II During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard. 389 devices, all model numbers. Z-0700-2013