Events

Device Recall Richard Wolf Medical Instrument Corp. ICart 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Richard Wolf Medical Instruments Corp. 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
    70220
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1240-2015
  • 사례 시작날짜
    2014-12-10
  • 사례 출판 날짜
    2015-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133375
  • 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
    Monitor, bed patient - Product Code KMI
  • 원인
    The transformers installed on carts used for richard wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.
  • 조치
    Field Action Notice letters dated December 10, 2014 were sent to both direct accounts (customers). The letters instructed customers to: 1) Instruct the biomed to bypass the integrated power grid on the cart and not to use the electrical system on the affected carts until a qualified Omni Corporation service technician is able to inspect and repair the carts; and 2) Omni Corporation will schedule a qualified Omni field service technician, in conjunction with Richard Wolf and the customer's biomed unit, to visit and replace the transformer on the cart.

Device

Device Recall Richard Wolf Medical Instrument Corp. ICart
  • 모델명 / 제조번호(시리얼번호)
    (NOTE: The listed serial numbers are for the carts manufactured and include those that were distributed.)   1) Part Number: 31113.801; Serial Numbers: 1306000, 1306007, 1306014, 1306021, 1306103, 1306001, 1306008, 1306015, 1306022, 1306104, 1306002, 1306009, 1306016, 1306023, 1306105, 1306003, 1306010, 1306017, 1306024, 1307100, 1306004, 1306011, 1306018, 1306100,  1307101, 1306005, 1306012, 1306019, 1306101, 1307102, 1306006, 1306013, 1306020, 1306102, 1317103.   2) Part Number: 31113.701; Serial Numbers: 11001, 11011, 11020, 11030, 11039, 11048, 11058, 11002, 11012, 11021, 11031, 11040, 11049, 11059, 11003, 11013, 11023, 11032, 11041, 11050, 11060, 11005, 11014, 11024, 11033, 11042, 11051, 11061, 11006, 11015, 11025, 11034, 11043, 11052, 11063, 11007, 11016, 11026, 11035, 11044, 11053, 11064, 11008, 11017, 11027, 11036, 11045, 11055, 11065, 11009, 11018, 11028, 11037, 11046, 11056, 11066, 11010, 11019, 11029, 11038, 11047, 11057, 11067.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    The I-Cart is used to store, transport, and power video equipment used in medical procedures.
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • 제조사 주소
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • 제조사 모회사 (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA