Events

EVOTECH Endoscope Cleaner and Reprocessor System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Sterilization Products 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
    75290
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0965-2017
  • 사례 출판 날짜
    2017-01-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149985
  • 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
    Accessories, cleaning, for endoscope - Product Code FEB
  • 원인
    Advanced sterilization products (asp) is recalling the evotech endoscope cleaner and reprocessor system because the hose may come loose and cause a leak.
  • 조치
    ASP has sent out Service Representatives to all impacted customers to inspect the hoses for the EVOTECH Endoscope Cleaner and Reprocessor System and will replace the hose if required. The firm issued a Technical Bulletin dated 8/22/2016. Customers were instructed to complete online training prior to performing the actions described in the bulletin and follow instructions. For orders and questions call 888-783-7723 or email: RA-ASPUS-ServPartOrd@aspus.jnj.com.

Device

EVOTECH Endoscope Cleaner and Reprocessor System
  • 모델명 / 제조번호(시리얼번호)
    UDI 10705037030958 Serial No. 5041150187 UDI 10705037030958 Serial No. 5041150188 UDI 10705037030958 Serial No. 5041150189 UDI 10705037030958 Serial No. 5041150192 UDI 10705037030958 Serial No. 5041150191 UDI 10705037030958 Serial No. 5041150190 UDI 10705037030958 Serial No. 5041150193 UDI 10705037030958 Serial No. 5041150205 UDI 10705037030958 Serial No. 5041150212 UDI 10705037030958 Serial No. 5041150207 UDI 10705037030958 Serial No. 5041150213 UDI 10705037030958 Serial No. 5041150206 UDI 10705037030958 Serial No. 5041150204 UDI 10705037030958 Serial No. 5041150210 UDI 10705037030958 Serial No. 5041150198 UDI 10705037030958 Serial No. 5041150228 UDI 10705037030958 Serial No. 5041150230 UDI 10705037030958 Serial No. 5041150229 UDI 10705037030958 Serial No. 5041150227 UDI 10705037030958 Serial No. 5041150226 UDI 10705037030958 Serial No. 5041150209 UDI 10705037030958 Serial No. 5041150231 UDI 10705037030958 Serial No. 5041150197 UDI 10705037030958 Serial No. 5041150236 UDI 10705037030958 Serial No. 5041150211 UDI 10705037030958 Serial No. 5041150235 UDI 10705037030958 Serial No. 5041150233 UDI 10705037030958 Serial No. 5041150234 UDI 10705037030958 Serial No. 5041150232 UDI 10705037030958 Serial No. 5041150196 UDI 10705037030958 Serial No. 5041150195 UDI 10705037030958 Serial No. 5041150199 UDI 10705037030958 Serial No. 5041150194 UDI 10705037030958 Serial No. 5041150202 UDI 10705037030958 Serial No. 5041150245 UDI 10705037030958 Serial No.5041150248 UDI 10705037030958 Serial No. 5041150246 UDI 10705037030958 Serial No. 5041150241 UDI 10705037030958 Serial No. 5041150247 UDI 10705037030958 Serial No. 5041150240 UDI 10705037030958 Serial No. 5041150242 UDI 10705037030958 Serial No. 5041150208 UDI 10705037030958 Serial No. 5041150239 UDI 10705037030958 Serial No. 5041150238 UDI 10705037030958 Serial No. 5041150237 UDI 10705037030958 Serial No. 5041150203 UDI 10705037030958 Serial No. 5041150200 UDI 10705037030958 Serial No. 5041150201 UDI 10705037030958 Serial No. 5041150244 UDI 10705037030958 Serial No. 5041150243 UDI 10705037030958 Serial No. 5041150251 UDI 10705037030958 Serial No. 5041150252 UDI 10705037030958 Serial No. 5041150250 UDI 10705037030958 Serial No. 5041150288 UDI 10705037030958 Serial No. 5041150290 UDI 10705037030958 Serial No. 5041150280 UDI 10705037030958 Serial No. 5041150253 UDI 10705037030958 Serial No. 5041150249 UDI 10705037030958 Serial No. 5041150254  UDI 10705037030958 Serial No. 5041150255  UDI 10705037030958 Serial No. 5041150282  UDI 10705037030958 Serial No. 5041150285  UDI 10705037030958 Serial No. 5041150286  UDI 10705037030958 Serial No. 5041150292  UDI 10705037030958 Serial No. 5041150287  UDI 10705037030958 Serial No. 5041150284  UDI 10705037030958 Serial No. 5041150289  UDI 10705037030958 Serial No. 5041150293  UDI 10705037030958 Serial No. 5041150302  UDI 10705037030958 Serial No. 5041150291  UDI 10705037030958 Serial No. 5041150301  UDI 10705037030958 Serial No. 5041150304  UDI 10705037030958 Serial No. 5041150305  UDI 10705037030958 Serial No. 5041150283  UDI 10705037030958 Serial No. 5041150328  UDI 10705037030958 Serial No. 5041150326 UDI 10705037030958 Serial No. 5041150306  UDI 10705037030958 Serial No. 5041150323  UDI 10705037030958 Serial No. 5041150324  UDI 10705037030958 Serial No. 5041150307  UDI 10705037030958 Serial No. 5041150310  UDI 10705037030958 Serial No. 5041150321  UDI 10705037030958 Serial No. 5041150320  UDI 10705037030958 Serial No. 5041150322  UDI 10705037030958 Serial No. 5041150303  UDI 10705037030958 Serial No. 5041150311  UDI 10705037030958 Serial No. 5041150308  UDI 10705037030958 Serial No. 5041150327  UDI 10705037030958 Serial No. 5041150325  UDI 10705037030958 Serial No. 5041150329  UDI 10705037030958 Serial No. 5041150330  UDI 10705037030958 Serial No. 5041150331  UDI 10705037030958 Serial No. 5041150333  UDI 10705037030958 Serial No. 5041150334  UDI 10705037030958 Serial No. 5041150341  UDI 10705037030958 Serial No. 5041150342  UDI 10705037030958 Serial No. 5041150343  UDI 10705037030958 Serial No. 5041150344  UDI 10705037030958 Serial No. 5041150345 UDI 10705037030958 Serial No. 5041150346  UDI 10705037030958 Serial No. 5041150347  UDI 10705037030958 Serial No. 5041150348  UDI 10705037030958 Serial No. 5041150349  UDI 10705037030958 Serial No. 5041150350  UDI 10705037030958 Serial No. 5041160377
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 || The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA