Events

Device Recall ViSi Mobile Chest Sensor (3 leadwire ECG, AAMI), 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sotera Wireless, Inc. 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
    65718
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1818-2013
  • 사례 시작날짜
    2013-05-23
  • 사례 출판 날짜
    2013-07-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119957
  • 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,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • 원인
    Sotera wireless, inc. is recalling the visi mobile monitoring system due to the potential for the chest sensor to cause a blister wound.
  • 조치
    Sotera sent an Urgent Product Recall letter dated May 23. 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to report any adverse reactions experienced with the use of this product and or quality problems to the FDA's MedWatch Program by: www.fda.gov/medwatch, (800) FDA-1008, fax (800) FDA-0178. Customers were also instructed to contact Sotera Wireless Technical Support at (866) 794-5526 for questions.

Device

Device Recall ViSi Mobile Chest Sensor (3 leadwire ECG, AAMI),
  • 모델명 / 제조번호(시리얼번호)
    Serial No. ACBE20120900183 ACBE20120900189 ACBE20120900205 ACBE20120900206 ACBE20121000217 ACBE20121000224 ACBE20121000225 ACBE20121000226 ACBE20121000231 ACBE20121000232 ACBE20121000236 ACBE20121000240 ACBE20121000245 ACBE20121000250 ACBE20121000252 ACBE20121000259 ACBE20121000260 ACBE20121000261 ACBE20121000262 ACBE20121000271 ACBE20121100292 ACBE20121100296 ACBE20121100300 ACBE20130200445 ACBE20120900211 ACBE20121000222 ACBE20121000237 ACBE20121000246 ACBE20121000263 ACBE20121100277 ACBE20121100280 ACBE20121100283 ACBE20121100287 ACBE20121100291 ACBE20121100356 ACBE20121100360 ACBE20121100364 ACBE20130100394 ACBE20130100395 ACBE20130100397 ACBE20130100398 ACBE20130100399 ACBE20130100401 ACBE20130100402 ACBE20130100404 ACBE20130100405 ACBE20130100410 ACBE20130100411 ACBE20130100412 ACBE20130100415 ACBE20130100417 ACBE20121000218 ACBE20121000227 ACBE20121000270 ACBE20121100282 ACBE20121100286 ACBE20121100288 ACBE20121100301 ACBE20121100350 ACBE20121100352 ACBE20121100355 ACBE20130100369 ACBE20130100370 ACBE20130100374 ACBE20130100375 ACBE20130100376 ACBE20130100378 ACBE20130100379 ACBE20130100380 ACBE20130100384 ACBE20130100385 ACBE20130100388 ACBE20130100390 ACBE20130100392 ACBE20130100393
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution including CA and UT.
  • 제품 설명
    ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 || The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
  • Manufacturer
    Sotera Wireless, Inc.

Manufacturer

Sotera Wireless, Inc.
  • 제조사 주소
    Sotera Wireless, Inc., 9444 Waples St, #280, San Diego CA 92121-2939
  • 제조사 모회사 (2017)
    Sotera Wireless Inc.
  • Source
    USFDA