Events

Device Recall GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    65755
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1833-2013
  • 사례 시작날짜
    2012-07-13
  • 사례 출판 날짜
    2013-07-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120056
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 원인
    Ge healthcare has recently become aware that during use of the voluson e6 or e8 systems, that an error message out of memory can be displayed which could cause the system to freeze. this is an intermittent behavior that also requires a certain workflow. this issue can be resolved by rebooting the system.
  • 조치
    No consignee letter was sent out. Starting on July 13, 2012, Field Engineers visited consignees and carried on instructions as per Field Modification Instruction (FMI 79044A). The Engineer returned the system to the customer and ensure acceptance. Before leaving the customer site have the staff operate the system. Ensure that: all settings are customized, all peripherals are functioning and all communications are working properly. We plan to update the software on all of the affected GE VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM that were distributed. As an effectiveness check, we will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures. Further questions please call 262-513-4122.

Device

Device Recall GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial #  D16290 D16293 D16294 D16295 D16296 D16297 D16299 D16300 D16301 D16302 D16303 D16304 D16305 D16306 D16309 D16310 D16311 D16312 D16313 D16314 D16315 D16316 D16318 D16319 D16326 D16335 D16336 D16337 D16338 D16339 D16340 D16341 D16342 D16343 D16345 D16346 D16362 D16366 D16367 D16368 D16370 D16371 D16372 D16373 D16374 D16375 D16377 D16378 D16396 D16398 D16399 D16400 D16401 D16402 D16403 D16404 D16405 D16406 D16432 D16433 D16434 D16435 D16436 D16437 D16438 D16439 D16440 D16441 D16453 D16458 D16460 D16461 D16462 D16466 D16467 D16468 D55513 D55514 D55515 D55519 D55520 D55521 D55522 D55538 D55539 D55540 D55541 D55543 D55549 D55550 D55551 D55565 D55566 D55568 D55578 D55579 D55580 D55581 D55582 D55598 D55603 D55605 D55606 D55615 D55616 D55617 D16407 D55524 D04446 D16477 D55516 D55534 D55557 D55588 D16239 D55576 D55623 D55625 D16348 D16349 D16350 D55552 D55553 D55554 D55555 D55560 D16254 D16257 D16257 D55336 D55337 D55338 D55348 D55595 D13829 D15232 D15425 D15973 D16193 D16245 D16248 D16255 D16260 D16262 D16317 D16324 D16334 D16344 D16352 D16358 D16369 D16380 D16384 D16385 D16390 D16393 D16424 D16445 D16448 D16454 D16455 D16464 D16480 D16481 D16482 D16483 D16484 D16486 D16487 D55437 D55517 D55548 D55575 D55593 D55607 D55608 D55611 D55612 D55621 D55624 D55627 D16240 D55518 D55572 D55573 D55574 D55610 D16442 D55510 D55599 D55622 D03382 D16256 D55544 D55629 D05257 D10516 D13472 D15189 D15444 D15454 D16235 D16242 D16244 D16246 D16251 D16264 D16265 D16277 D16279 D16280 D16281 D16284 D16331 D16333 D16347 D16353 D16382 D16387 D16388 D16389 D16409 D16410 D16411 D16412 D16413 D16414 D16415 D16427 D16428 D16429 D16443 D16444 D16449 D16478 D55532 D55556 D55585 D55586 D55587 D00716 D04334 D11004 D15447 D16241 D16258 D16263 D16276 D16286 D16287 D16289 D16291 D16292 D16307 D16327 D16379 D16391 D16408 D16416 D16423 D16425 D16426 D16430 D16488 D55015 D55472 D55525 D55526 D55527 D55528 D55530 D55535 D55542 D55545 D55567 D55589 D55590 D55591 D55592 D55596 D55597 D55632 D55633 D11463 D16250 D16355 D16363 D16364 D16479 D03377 D16288 D16325 D55563 D55601 D00688 D03104 D04391 D05445 D11398 D11419 D13350 D16267 D16269 D16271 D16272 D16273 D16274 D16321 D16322 D16323 D16419 D16420 D16422 D55546 D16236 D16259 D16351 D55561 D16446 D55531 D55630 D16397 D55594 D16332 D16465 D16392 D16261 D16330 D16473 D16475 D55558 D55583 D55584 D16320 D55577 D55602 D55631 D00101 D00853 D16328 D16329 D16470 D03958 D16252 D16361 D55562 D16395 D16472 D55626 D55628 D55414 D55533 D01077 D16243 D16253 D16268 D16308 D16381 D16451 D16463 D55570 D55600 D55634 D16418 D16270 D16282 D16283 D16285 D55559 D16237 D16359 D16365 D16452 D16476 D55571
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRIL, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF MOLDOVA, NETHERLANDS, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, KINGDOM OF SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA.
  • 제품 설명
    GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. || The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA