Events

Flex Cardio Patient Monitoring System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Invivo Corporation 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
    73196
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2760-2016
  • 사례 시작날짜
    2015-10-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145526
  • 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
    Display of spo2 and non-invasive blood pressure (nibp) measurements may freeze.
  • 조치
    Phillips Medical Systems sent out a letter to their customers, dated October 19, 2015. The letter notified customers and distributors of the voluntary recall of the Xper Flex Cardio Patient Monitoring System, and identified the product issue as "Display o fSpO2 and NIBP measurements may freeze". Phillips assured customers that the recalled device can be used if each monitored patient is closely observed and not left unattended. These directions are directed within the instructions of the manual for regular use. Continued use is advised until Phillips contacts the individual customer to correct the issue with a software update. Some hardware is more dated, so software updates will require special handling. If customers have any additional questions, they are encouraged to contact their local Phillips representative. For further questions, please call (877) 468- 4861 option 1 then option 2.

Device

Flex Cardio Patient Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Product: Xper Flex Cardio Patient Monitoring System Model Numbers FC2010 and FC2020 Serial Numbers by Product: 453564241901 USI203010414 USI244000011 USI234000052 USI521000021 USI343000067 USI343000030 USI337000084 USI334000030 USI331000048 US 1328000004 USI324000049 USI324000017 USI319000088 US1319000043 USI319000016 USI251000082 USI251000054 USI251000042 USI251000007 USI25000054 USI248000041 USI234000090 USI224000028 USI203010318 USI202010188 USI343000053 USI251000005 USI231000001 US1334000034 USI334000018 USI319000053 USI234000045 us 1343000064 us 1343000018 us 1334000026 us 1334000008 USI324000025 USI311000001 USI239000005 USI234000054 USI224000026 USI203010419 USI203010418 USI203010411 USI203010403 USI203010391 US1203010372 USI203010301 US120301 0256 USI20201 0209 USII0701 0022 USI343000015 USI334000028 USI319000077 USI337000059 US1337000022 USI33!000014 USI319000087 USI319000061 US1319000002 USI244000002 USI239000049 USI203010392 USI203010264 US1201010131 USI109010102 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    Cardiovascular Devices
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    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to the states of :AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, TN, UT, VA, WA, WI, WV, Alaska, Hawaii, & Washington, DC. Worldwide Distribution to the countries of : Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Cayman Islands, Chile, Columbia, Croatia, Democratic Republic of Congo, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Republic of Korea, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, State of Palestine, Panama, Papua New Guinea, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Taiwan Province, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United Republic of Tanzania, Uzbekistan, & Vietnam.
  • 제품 설명
    The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • 제조사 주소
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA